Method for inactivating enveloped viruses using TDAO in purified plasma

Abstract

The present disclosure relates to a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, comprising contacting the plasma sample or plasma fraction thereof with a surfactant; one or more surfactant adsorbers and / or a chromatography step; compositions comprising the purified plasma sample or plasma fraction thereof and uses thereof.

Description

[0001] METHOD OF PURIFICATION

[0002] RELATED APPLICATION DATA

[0003] This application claims priority from European Patent Application No.

[0004] 25165069.3 filed on 20 March 2025 and entitled “Method of purification”, the entire contents of which is hereby incorporated by reference.

[0005] FIELD

[0006] The present disclosure relates to a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, comprising contacting the plasma sample or plasma fraction thereof with a surfactant; one or more surfactant adsorbers and / or a chromatography step; compositions comprising the purified plasma sample or plasma fraction thereof and uses thereof.

[0007] BACKGROUND

[0008] Protein purification is one of the most costly aspects of therapeutic protein production. To date, several methods of plasma fractionation have been developed. Existing methods of plasma protein purification includes chromatography (e.g. affinity chromatography, anion exchange chromatography, hydrophobic interaction chromatography, SE-HPLC) and non-chromatography (e.g. precipitation and liquid extraction) purification methods.

[0009] Current methods require extremely high volumes of raw material and can often result in poor yield of some plasma protein fractions due to additional processing steps required to remove protein aggregates. Major obstacles also include the high cost and time involved in purification and the need to ensure that the product is of a suitable quality (e.g. purity and stability) for therapeutic use.

[0010] Immunoglobulin G (IgG) is one of the most abundant proteins in plasma and is responsible for e.g., toxin neutralization, complement activation and opsonisation. IgG purified from human plasma is used for prophylactic prevention of infections in immunodeficient patients, replacement therapy for antibody deficiencies in patients, and the treatment of conditions relating to immune deficiencies, inflammatory and autoimmune diseases and acute infections in patients. Plasma derived immunoglobulin has become a major plasma product and world-wide consumption is increasing. Human immunoglobulin products, both hyperimmune (or ‘specific’) and normal (or ‘nonspecific’), predominantly consist of IgG. Hyperimmune immunoglobulin products include hepatitis B, tetanus, varicella-zoster and rabies immunoglobulins; eachcontaining a known concentration of particular antibodies. The antibody specificities in normal polyvalent human immunoglobulins (IG) mirror those in the donor population. A list of FDA Approved IGs is provided at https: / / www.fda.gov / vaccines-blood-biologics / approved-blood-products / immune-globulins. There are currently several commercial intravenous IG (IVIG) products (typically 5% or 10% (w / v) stabilised solutions) available including Privigen® (CSL Behring), Flebogamma® (Grifols), Gamunex®-C (Grifols), Gammagard® (Takeda), and Octagam® (Octapharma). More recently, subcutaneous IG (SCIG) administration has become available. Commercial SCIG products (typically 10%, 16.5% or 20% (w / v) stabilised solutions) include Hizentra® (CSL Behring), Gamunex®-C (Grifols), Xembify® (Grifols), Cutaquig® (Octapharma) and Cuvitru® (Takeda). Other IG products are administered intramuscularly (IMIG).

[0011] At present, up to 70-75% of the IgG present in plasma may be recovered from plasma using existing technologies.

[0012] It will therefore be apparent to the skilled person that there is a need in the art for improved methods of separating plasma proteins from plasma samples or fractions thereof.

[0013] SUMMARY

[0014] The present disclosure is based on the inventors’ identification of a method of purifying a plasma protein (e.g., IgG) from a plasma sample or a plasma fraction thereof at high yields (e.g., >75%). The method also allows for IgG to be recovered from a plasma sample or a fraction thereof at high purity (e.g., >95%). In particular, the inventors have found that the use of a low concentration surfactant (i.e., 0.01-0.5%) viral inactivation step and subsequent downstream purification resulted in purification of high yields and purity of immunoglobulin G (IgG) with minimal impact on IgG subclass distribution (i.e., IgGl, IgG2, IgG3 and IgG4), and impurity levels (such as IgA, IgM and Factor XI). Importantly, the inventors found that the low surfactant concentrations were sufficient to achieve inactivation of viruses in alignment with relevant regulatory requirements (e.g., the current European Medicines Agency (EMA) guidelines, 21 July 2011 EMA / CHMP / BWP / 706271 / 2010). In addition, the inventors found that the use of one or more surfactant adsorbers (e.g., an activated carbon adsorber) adequately removed residual surfactant without any impact on the quality or efficacy of the IgG product.

[0015] Accordingly, the findings by the inventors provide the basis for a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof. The findings also provide the basis for a method of producing a viral inactivated plasmaprotein preparation from a plasma sample or a plasma fraction thereof. The findings by the inventors further provide the basis for a composition comprising a viral inactivated plasma protein preparation or a purified plasma protein preparation, as well as the use of the composition for treating, preventing and / or delaying progression of a condition in a subject.

[0016] Thus, the present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w), or between 0.01% and 0.5% (w / v), or between 0.01% and 0.5% (v / v).

[0017] The present disclosure also provides a method for purifying a plasma protein, the method comprising contacting a plasma sample or plasma fraction comprising IgM with TDAO at a concentration of at least 0.25% (w / w) at a pH below 5.0 thereby producing the purified plasma protein, wherein contacting the sample with TDAO reduces the level of IgM in the purified plasma protein relative to the level of IgM in the sample prior to contacting with TDAO.

[0018] The present disclosure further provides amethod for producing a plasma protein preparation, the method comprising contacting a sample comprising the plasma protein and IgM with TDAO at a concentration of at least 0.25% (w / w) at a pH below 5.0, and recovering a plasma protein preparation, wherein contacting the sample with TDAO reduces the level of IgM in the recovered plasma protein composition relative to the level of IgM in the sample prior to contacting with TDAO.

[0019] In one example, the method further comprises a chromatography step comprising a chromatography medium.

[0020] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0021] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); and

[0022] (ii) a chromatography step comprising a chromatography medium;

[0023] wherein the method produces a purified plasma protein preparation.

[0024] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0025] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); and(ii) a chromatography step comprising a chromatography medium;

[0026] wherein the method produces a purified plasma protein preparation.

[0027] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0028] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); and

[0029] (ii) a chromatography step comprising a chromatography medium;

[0030] wherein the method produces a purified plasma protein preparation.

[0031] In one example, the method further comprises contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) prior to the chromatography step, thereby to produce a viral inactivated plasma protein preparation.

[0032] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0033] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0034] (iii)collecting the filtrate from the surfactant adsorber,

[0035] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0036] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0037] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0038] (iii)collecting the filtrate from the surfactant adsorber,

[0039] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0040] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0041] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0042] (iii)collecting the filtrate from the surfactant adsorber,

[0043] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0044] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0045] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0046] (iii)collecting the filtrate from the surfactant adsorber,

[0047] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0048] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0049] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0050] (iii)collecting the filtrate from the surfactant adsorber,

[0051] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0052] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0053] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v);

[0054] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0055] (iii)collecting the filtrate from the surfactant adsorber,

[0056] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0057] In one example, the plasma sample or plasma fraction thereof is an affinity chromatography eluate. For example, the plasma sample or plasma fraction thereof has been previously subjected to an affinity chromatography medium. In one example, the affinity chromatography medium comprises a ligand that specifically binds to one or more or all subclasses of IgG (i.e., IgGl, IgG2, IgG3 and / or IgG4). For example, the affinity chromatography medium comprises a ligand that specifically binds to IgGl. In another example, the affinity chromatography medium comprises a ligand that specifically binds to IgG2. In a further example, the affinity chromatography mediumcomprises a ligand that specifically binds to IgG3. In one example, the affinity chromatography medium comprises a ligand that specifically binds to IgG4. example, the affinity chromatography medium comprises a ligand that specifically binds to IgGl, IgG2, IgG3 and IgG4. In one example, the affinity chromatography medium comprises a ligand capable of specifically binding to all subclasses of human IgG. In one example, the affinity chromatography medium specifically binds a CH3 domain of human IgG. In one example, the affinity chromatography medium specifically binds a CH2 domain and a CH3 domain of human IgG. In one example, the affinity chromatography medium does not bind a CHI domain of human IgG.

[0058] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.02 and 0.5% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.05 and 0.5% (w / w) of the surfactant. For example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.1 and 0.5% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.5% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.45% (w / w) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.4% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22 and 0.4% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.35% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.3% (w / w) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22 and 0.3% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.26% (w / w) of the surfactant.

[0059] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.01% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02%, or 0.03%, or 0.04%, or 0.05%, or 0.06%, or 0.07%, or 0.08%, or 0.08% (w / w) ofthe surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.1% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.15% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.2% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.21% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.22% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.23% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.24% (w / w) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.25% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.26% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.27% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.28% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.29% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.3% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.31% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.32% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.33% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.35% (w / w) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.4% (w / w) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.45% (w / w) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.5% (w / w) of the surfactant.

[0060] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.02 and 0.5% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between0.05 and 0.5% (w / v) of the surfactant. For example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.1 and 0.5% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.5% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.45% (w / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.4% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22 and 0.4% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.35% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.3% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.26% (w / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22 and 0.3% (w / v) of the surfactant.

[0061] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.01% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02%, or 0.03%, or 0.04%, or 0.05%, or 0.06%, or 0.07%, or 0.08%, or 0.08% (w / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.1% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.15% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.2% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.21% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.22% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.23% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.24% (w / v) of the surfactant. In a further example, the method comprisescontacting the plasma sample or plasma fraction thereof with about 0.25% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.26% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.27% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.28% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.29% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.3% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.31% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.32% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.33% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.35% (w / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.4% (w / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.45% (w / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.5% (w / v) of the surfactant.

[0062] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.02 and 0.5% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.05 and 0.5% (v / v) of the surfactant. For example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.1% and 0.5% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.5% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.45% (v / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.4% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.4% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.35% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereofwith between 0.2% and 0.3% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.26% (v / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.3% (v / v) of the surfactant.

[0063] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.01% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.03%, or 0.04%, or 0.05%, or 0.06%, or 0.07%, or 0.08%, or 0.08% (v / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.1% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.15% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.2% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.21% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.22% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.23% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.24% (v / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.25% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.26% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.27% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.28% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.29% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.3% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.31% (v / v) of thesurfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.32% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.33% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.35% (v / v) of the surfactant. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.4% (v / v) of the surfactant. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.45% (v / v) of the surfactant. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.5% (v / v) of the surfactant.

[0064] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0065] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0066] (iii) collecting the filtrate from the surfactant adsorber,

[0067] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0068] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0069] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0070] (iii) collecting the filtrate from the surfactant adsorber,

[0071] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0072] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0073] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0074] (iii) collecting the filtrate from the surfactant adsorber,wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0075] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0076] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0077] (iii) collecting the filtrate from the surfactant adsorber,

[0078] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0079] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0080] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0081] (iii) collecting the filtrate from the surfactant adsorber,

[0082] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0083] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0084] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0085] (iii) collecting the filtrate from the surfactant adsorber,

[0086] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0087] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0088] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0089] (iii) collecting the filtrate from the surfactant adsorber,

[0090] wherein the filtrate comprises a viral inactivated plasma protein preparation.The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0091] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0092] (iii) collecting the filtrate from the surfactant adsorber,

[0093] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0094] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0095] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0096] (iii) collecting the filtrate from the surfactant adsorber,

[0097] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0098] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0099] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0100] (iii) collecting the filtrate from the surfactant adsorber,

[0101] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0102] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0103] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0104] (iii) collecting the filtrate from the surfactant adsorber,

[0105] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0106] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0107] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0108] (iii) collecting the filtrate from the surfactant adsorber,

[0109] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0110] In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 10 minutes and 24 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 20 minutes and 24 hours. For example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 20 minutes and 20 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 20 minutes and 18 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 20 minutes and 15 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 1 hour and 15 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 2 hours and 15 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 3 hours and 15 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 4 hours and 15 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 4 hours and 13 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 4 and 12 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 4 hours and 10 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 4 hours and 8 hours.

[0111] In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of at least 5 minutes. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of at least 10 minutes. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a periodof at least 15 minutes. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of at least 20 minutes. For example, the method comprises incubating the plasma sample or plasma fraction thereof for a period of at least 30 minutes. In another example, the method comprises incubating the plasma sample or plasma fraction thereof for a period of at least 40 minutes. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for a period of at least 50 minutes. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for at least 60 minutes (i.e., 1 hour). In another example, the method comprises incubating the plasma sample or plasma fraction thereof for at least 1.5 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for at least 2 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for at least 2.5 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof for at least 3 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for at least 3.5 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for at least 4 hours.

[0112] In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of about 15 minutes. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for a period of about 20 minutes. For example, the method comprises incubating the plasma sample or plasma fraction thereof for a period of about 30 minutes. In another example, the method comprises incubating the plasma sample or plasma fraction thereof for a period of about 40 minutes. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for a period of about 50 minutes. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for about 60 minutes (i.e., 1 hour). In another example, the method comprises incubating the plasma sample or plasma fraction thereof for about 1.5 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for about 2 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for about 2.5 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof for about 3 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for about 3.5 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for about 4 hours. In another example, the method comprises incubating the plasma sample or plasma fractionthereof for about 5 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for about 6 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for about 7 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof for about 8 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for about 9 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for about 10 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof for about 11 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for about 12 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for about 13 hours. In another example, the method comprises incubating the plasma sample or plasma fraction thereof for about 14 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for about 15 hours. In one example, the method comprises incubating the plasma sample or plasma fraction thereof for about 16 hours, or about 17 hours, or about 18 hours, or about 19 hours, or about 20 hours. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof for about 21 hours, or about 22 hours, or about 23 hours, or about 24 hours.

[0113] In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of between 4.0 and 7.0. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of between 4.0 and 6.5. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of between 4.0 and 6.0. For example, the pH is about 4.0, or about 4.1, or about 4.2, or about 4.3, or about 4.4, or about 4.5. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of about 4.5. In another example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of about 4.6, or about 4.7, or about 4.8, or about 4.9. In another example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of about 5.0. In a further example, the pH is about 5.1, or about 5.2, or about 5.3, or about 5.4. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of about 5.5. For example, the pH is about 5.6, or about 5.7, or about 5.8, or about 5.9. In another example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of about 6.0. In a further example, the pH is about 6.1,or about 6.2, or about 6.3, or about 6.4. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of about 6.5. For example, the pH is about 6.6, or about 6.7, or about 6.8, or about 6.9. In another example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a pH of about 7.0.

[0114] In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a temperature of between 10°C and 37°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a temperature of between 10°C and 35°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a temperature of between 10°C and 30°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a temperature of between 10°C and 24°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a temperature of between 13°C and 24°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant at a temperature of between 18°C and 24°C. For example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of between 20°C and 24°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 10°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 13°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 15°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 18°C. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 19°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 20°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 21 °C. In a further example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 22°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 22.5°C. In one example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 23°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 24°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature ofabout 27°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 30°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 32°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 35°C. In another example, the method comprises incubating the plasma sample or plasma fraction thereof at a temperature of about 37°C.

[0115] In one example, the method comprises incubating the plasma sample or plasma fraction thereof at room temperature. The skilled person will be aware that room temperature is typically between 18°C and 24°C.

[0116] In one example, the plasma sample or plasma fraction thereof has a low conductivity during incubation with the surfactant. For example, the plasma sample or plasma fraction thereof has a low conductivity during incubation with the TDAO. In one example, the plasma sample or plasma fraction thereof has a conductivity of less than 5.50 mS / cm during incubation with the surfactant. For example, the plasma sample or plasma fraction thereof has a conductivity of less than 5.50 mS / cm during incubation with the TDAO. In one example, the plasma sample or plasma fraction thereof has a conductivity of less than 5.00 mS / cm during incubation with the surfactant. For example, the plasma sample or plasma fraction thereof has a conductivity of less than 5.00 mS / cm during incubation with the TDAO. In one example, the plasma sample or plasma fraction thereof has a conductivity of less than 4.50 mS / cm during incubation with the surfactant. For example, the plasma sample or plasma fraction thereof has a conductivity of less than 4.50 mS / cm during incubation with the TDAO. In one example, the plasma sample or plasma fraction thereof has a conductivity of less than 2.00 mS / cm during incubation with the surfactant. For example, the plasma sample or plasma fraction thereof has a conductivity of less than 2.00 mS / cm during incubation with the TDAO.

[0117] In one example, the conductivity of the plasma sample or plasma fraction thereof during incubation with the surfactant or TDAO is between 0.50 and 5.50 mS / cm. In one example, the conductivity of the plasma sample or plasma fraction thereof during incubation with the surfactant or TDAO is between 0.50 and 5.00 mS / cm. In one example, the conductivity of the plasma sample or plasma fraction thereof during incubation with the surfactant or TDAO is between 0.50 and 4.50 mS / cm. For example, between 0.50 and 4.00 mS / cm, or between 0.50 and 3.50 mS / cm, or between 0.50 and 3.00 mS / cm. In another example, the conductivity of the plasma sample or plasma fraction thereof during incubation with the surfactant or TDAO is between 0.50 and 2.50 mS / cm. For example, between 0.50 and 2.00 mS / cm. In another example, theconductivity of the plasma sample or plasma fraction thereof during incubation with the surfactant or TDAO is between 1.00 and 4.50 mS / cm. For example, between 1.0 and 4 mS / cm, or between 1.00 and 3.50 mS / cm, or between 1.00 and 3.00 mS / cm. In another example, the conductivity of the plasma sample or plasma fraction thereof during incubation with the surfactant or TDAO is between 1.00 and 2.50 mS / cm. For example, between 1.00 and 2.00 mS / cm.

[0118] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0119] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w) and at a pH of between 4.0 and 7.0;

[0120] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0121] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0122] (iv) collecting the filtrate from the surfactant adsorber,

[0123] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0124] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0125] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w) and at a pH of between 4.0 and 7.0;

[0126] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0127] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0128] (iv) collecting the filtrate from the surfactant adsorber,

[0129] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0130] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w) and at a pH of between 4.0 and 7.0;

[0131] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0132] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0133] (iv) collecting the filtrate from the surfactant adsorber,

[0134] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0135] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0136] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w) and at a pH of between 4.0 and 7.0;

[0137] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0138] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0139] (iv) collecting the filtrate from the surfactant adsorber,

[0140] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0141] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0142] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w) and at a pH of between 4.0 and 7.0;

[0143] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0144] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0145] (iv) collecting the filtrate from the surfactant adsorber,

[0146] wherein the filtrate comprises a viral inactivated plasma protein preparation.The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0147] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w) and at a pH of between 4.0 and 7.0;

[0148] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0149] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0150] (iv) collecting the filtrate from the surfactant adsorber,

[0151] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0152] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0153] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w) and at a pH of between 4.0 and 7.0;

[0154] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0155] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0156] (iv) collecting the filtrate from the surfactant adsorber,

[0157] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0158] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0159] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w) and at a pH of between 4.0 and 7.0;

[0160] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0161] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0162] (iv) collecting the filtrate from the surfactant adsorber,wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0163] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0164] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w) and at a pH of between 4.0 and 7.0;

[0165] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0166] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0167] (iv) collecting the filtrate from the surfactant adsorber,

[0168] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0169] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0170] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w) and at a pH of between 4.0 and 7.0;

[0171] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0172] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0173] (iv) collecting the filtrate from the surfactant adsorber,

[0174] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0175] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0176] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w) and at a pH of between 4.0 and 7.0;

[0177] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0178] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0179] (iv) collecting the filtrate from the surfactant adsorber,wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0180] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0181] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w) and at a pH of between 4.0 and 7.0;

[0182] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0183] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0184] (iv) collecting the filtrate from the surfactant adsorber,

[0185] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0186] In one example, the surfactant is Myristyldimethylamine-N-oxide (also known as A, A-Dimethyltetradecylamine A -oxi de or TDAO).

[0187] In one example, the surfactant comprises 0.2 to 0.3% (w / w) TDAO.

[0188] In one example, the surfactant comprises 0.22 to 0.32% (w / w) TDAO.

[0189] In one example, the surfactant comprises 0.22 to 0.30% (w / w) TDAO.

[0190] In one example, the surfactant comprises 0.22 to 0.28% (w / w) TDAO.

[0191] In one example, the surfactant comprises 0.22 to 0.26% (w / w) TDAO.

[0192] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.02% and 0.5% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.05% and 0.5% (w / w) TDAO. For example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.1 and 0.5% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.5% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.45% (w / w) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.4% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.4% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.35% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof withbetween 0.2% and 0.3% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.26% (w / w) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22 and 0.3% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22 and 0.32% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.25% and 0.29% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.25% and 0.28% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.26% and 0.29% (w / w) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.27 and 0.29% (w / w) TDAO. For example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.27 and 0.286% (w / w) TDAO.

[0193] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.01% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02%, or 0.03%, or 0.04%, or 0.05%, or 0.06%, or 0.07%, or 0.08%, or 0.08% (w / w) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.1% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.15% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.2% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.21% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.22% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.23% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.24% (w / w) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.25% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.26% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereofwith about 0.27% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.28% (w / w) TDAO. For example, about 0.278%. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.29% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.3% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.31% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.32% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.33% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.35% (w / w) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.4% (w / w) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.45% (w / w) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.5% (w / w) TDAO.

[0194] In one example, the surfactant comprises 0.2 to 0.3% (w / v) TDAO.

[0195] In one example, the surfactant comprises 0.22 to 0.32% (w / v) TDAO.

[0196] In one example, the surfactant comprises 0.22 to 0.30% (w / v) TDAO.

[0197] In one example, the surfactant comprises 0.22 to 0.28% (w / v) TDAO.

[0198] In one example, the surfactant comprises 0.22 to 0.26% (w / v) TDAO.

[0199] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.02% and 0.5% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.05% and 0.5% (w / v) TDAO. For example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.1 and 0.5% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.5% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.45% (w / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.4% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.4% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.35% (w / v) TDAO. In another example,the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.3% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.26% (w / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.3% (w / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.25% and 0.29% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.25% and 0.28% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.26% and 0.29% (w / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.27 and 0.29% (w / v) TDAO.

[0200] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.01% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02%, or 0.03%, or 0.04%, or 0.05%, or 0.06%, or 0.07%, or 0.08%, or 0.08% (w / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.1% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.15% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.2% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.21% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.22% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.23% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.24% (w / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.25% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.26% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.27% (w / v) TDAO. In another example, the method comprises contactingthe plasma sample or plasma fraction thereof with about 0.28% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.29% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.3% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.31% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.32% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.33% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.35% (w / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.4% (w / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.45% (w / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.5% (w / v) TDAO.

[0201] In one example, the surfactant comprises 0.2 to 0.3% (v / v) TDAO.

[0202] In one example, the surfactant comprises 0.22 to 0.32% (v / v) TDAO.

[0203] In one example, the surfactant comprises 0.22 to 0.30% (v / v) TDAO.

[0204] In one example, the surfactant comprises 0.22 to 0.28% (v / v) TDAO.

[0205] In one example, the surfactant comprises 0.22 to 0.26% (v / v) TDAO.

[0206] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.02% and 0.5% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.05% and 0.5% (v / v) TDAO. For example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.1% and 0.5% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.5% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.45% (v / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.4% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.4% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.2% and 0.35% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof withbetween 0.2% and 0.3% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.26% (v / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.3% (v / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.25% and 0.29% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.25% and 0.28% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.26% and 0.29% (v / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with between 0.27 and 0.29% (v / v) TDAO.

[0207] In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.01% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.02%, or 0.03%, or 0.04%, or 0.05%, or 0.06%, or 0.07%, or 0.08%, or 0.08% (v / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.1% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.15% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.2% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.21% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.22% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.23% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.24% (v / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.25% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.26% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.28% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.29% (v / v) TDAO. In one example, the methodcomprises contacting the plasma sample or plasma fraction thereof with about 0.3% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.31% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.32% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.33% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.35% (v / v) TDAO. In one example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.4% (v / v) TDAO. In another example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.45% (v / v) TDAO. In a further example, the method comprises contacting the plasma sample or plasma fraction thereof with about 0.5% (v / v) TDAO.

[0208] In one example, the surfactant contacts the plasma sample or plasma fraction thereof in the presence of tri(n-butyl)phosphate (TnBP). In one example, the surfactant contacts the plasma sample or plasma fraction thereof in combination with TnBP. For example, the surfactant is in a composition comprising the surfactant and TnBP.

[0209] In one example, the surfactant contacts the plasma sample or plasma fraction thereof in the absence of TnBP. For example, the viral inactivation step does not comprise contacting the plasma sample or plasma fraction thereof with TnBP.

[0210] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0211] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO; and

[0212] (ii) a chromatography step comprising a chromatography medium;

[0213] wherein the method produces a purified plasma protein preparation.

[0214] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0215] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0216] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0217] (iii) collecting the filtrate from the surfactant adsorber,

[0218] wherein the filtrate comprises a viral inactivated plasma protein preparation.The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0219] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;

[0220] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0221] (iii) collecting the filtrate from the surfactant adsorber,

[0222] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0223] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0224] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;

[0225] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0226] (iii) collecting the filtrate from the surfactant adsorber,

[0227] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0228] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0229] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[0230] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0231] (iii) collecting the filtrate from the surfactant adsorber,

[0232] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0233] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0234] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[0235] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0236] (iii) collecting the filtrate from the surfactant adsorber,

[0237] wherein the filtrate comprises a viral inactivated plasma protein preparation.The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0238] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[0239] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0240] (iii) collecting the filtrate from the surfactant adsorber,

[0241] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0242] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0243] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[0244] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0245] (iii) collecting the filtrate from the surfactant adsorber,

[0246] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0247] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0248] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;

[0249] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0250] (iii) collecting the filtrate from the surfactant adsorber,

[0251] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0252] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0253] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;

[0254] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0255] (iii) collecting the filtrate from the surfactant adsorber,

[0256] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0257] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[0258] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0259] (iii) collecting the filtrate from the surfactant adsorber,

[0260] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0261] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0262] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[0263] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0264] (iii) collecting the filtrate from the surfactant adsorber,

[0265] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0266] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0267] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[0268] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0269] (iii) collecting the filtrate from the surfactant adsorber,

[0270] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0271] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0272] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[0273] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0274] (iii) collecting the filtrate from the surfactant adsorber,

[0275] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0276] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0277] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO and at a pH of between 4.0 and 7.0;(ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0278] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0279] (iv) collecting the filtrate from the surfactant adsorber,

[0280] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0281] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0282] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0283] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0284] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0285] (iv) collecting the filtrate from the surfactant adsorber,

[0286] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0287] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0288] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0289] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0290] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0291] (iv) collecting the filtrate from the surfactant adsorber,

[0292] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0293] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0294] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0295] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0296] (iv) collecting the filtrate from the surfactant adsorber,

[0297] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0298] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0299] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0300] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0301] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0302] (iv) collecting the filtrate from the surfactant adsorber,

[0303] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0304] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0305] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0306] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0307] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0308] (iv) collecting the filtrate from the surfactant adsorber,

[0309] wherein the filtrate comprises a viral inactivated plasma protein preparation.The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0310] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0311] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0312] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0313] (iv) collecting the filtrate from the surfactant adsorber,

[0314] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0315] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0316] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0317] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0318] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0319] (iv) collecting the filtrate from the surfactant adsorber,

[0320] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0321] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0322] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0323] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0324] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0325] (iv) collecting the filtrate from the surfactant adsorber,

[0326] wherein the filtrate comprises a viral inactivated plasma protein preparation.The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0327] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0328] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0329] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0330] (iv) collecting the filtrate from the surfactant adsorber,

[0331] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0332] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0333] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0334] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0335] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0336] (iv) collecting the filtrate from the surfactant adsorber,

[0337] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0338] The present disclosure also provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0339] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0340] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0341] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0342] (iv) collecting the filtrate from the surfactant adsorber,

[0343] wherein the filtrate comprises a viral inactivated plasma protein preparation.In one example, the method further comprises a chromatography step comprising a chromatography medium. In one example, the method further comprises contacting the filtrate to a chromatography medium.

[0344] In one example, the chromatography step is operated in flow through mode. For example, the method further comprises collecting the flow through from the chromatography medium. It will be apparent to the skilled person that when the chromatography step is operated in flow through mode, the plasma protein is collected in the flowthrough (i.e., the impurities bind to the chromatography medium). In another example, the chromatography step is operated in bind-and-elute mode. For example, the plasma protein binds to the chromatography medium and is eluted from the chromatography medium. In one example, when the chromatography step is operated in bind-and-elute mode, the plasma protein is eluted during a post-wash step. For example, the impurities are collected in the flowthrough.

[0345] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0346] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0347] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0348] (iii) collecting the filtrate from the surfactant adsorber,

[0349] (iv) contacting the filtrate to a chromatography medium;

[0350] (v) collecting the plasma protein from the chromatography medium;

[0351] wherein the method produces a purified plasma protein preparation.

[0352] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0353] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;

[0354] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0355] (iii) collecting the filtrate from the surfactant adsorber,

[0356] (iv) contacting the filtrate to a chromatography medium;

[0357] (v) collecting the plasma protein from the chromatography medium;

[0358] wherein the method produces a purified plasma protein preparation.The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0359] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;

[0360] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0361] (iii) collecting the filtrate from the surfactant adsorber,

[0362] (iv) contacting the filtrate to a chromatography medium;

[0363] (v) collecting the plasma protein from the chromatography medium;

[0364] wherein the method produces a purified plasma protein preparation.

[0365] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0366] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[0367] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0368] (iii) collecting the filtrate from the surfactant adsorber,

[0369] (iv) contacting the filtrate to a chromatography medium;

[0370] (v) collecting the plasma protein from the chromatography medium;

[0371] wherein the method produces a purified plasma protein preparation.

[0372] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0373] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[0374] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0375] (iii) collecting the filtrate from the surfactant adsorber,

[0376] (iv) contacting the filtrate to a chromatography medium;

[0377] (v) collecting the plasma protein from the chromatography medium;

[0378] wherein the method produces a purified plasma protein preparation.

[0379] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[0380] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0381] (iii) collecting the filtrate from the surfactant adsorber,

[0382] (iv) contacting the filtrate to a chromatography medium;

[0383] (v) collecting the plasma protein from the chromatography medium;

[0384] wherein the method produces a purified plasma protein preparation.

[0385] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0386] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[0387] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0388] (iii) collecting the filtrate from the surfactant adsorber,

[0389] (iv) contacting the filtrate to a chromatography medium;

[0390] (v) collecting the plasma protein from the chromatography medium;

[0391] wherein the method produces a purified plasma protein preparation.

[0392] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0393] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0394] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0395] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0396] (iv) collecting the filtrate from the surfactant adsorber,

[0397] (v) contacting the filtrate to a chromatography medium;

[0398] (vi) collecting the plasma protein from the chromatography medium;

[0399] wherein the method produces a purified plasma protein preparation.The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0400] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0401] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0402] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0403] (iv) collecting the filtrate from the surfactant adsorber,

[0404] (v) contacting the filtrate to a chromatography medium;

[0405] (vi) collecting the plasma protein from the chromatography medium;

[0406] wherein the method produces a purified plasma protein preparation.

[0407] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0408] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0409] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0410] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0411] (iv) collecting the filtrate from the surfactant adsorber,

[0412] (v) contacting the filtrate to a chromatography medium;

[0413] (vi) collecting the plasma protein from the chromatography medium;

[0414] wherein the method produces a purified plasma protein preparation.

[0415] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0416] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO and at a pH of between 4.0 and 7.0;(ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0417] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0418] (iv) collecting the filtrate from the surfactant adsorber,

[0419] (v) contacting the filtrate to a chromatography medium;

[0420] (vi) collecting the plasma protein from the chromatography medium;

[0421] wherein the method produces a purified plasma protein preparation.

[0422] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0423] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0424] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0425] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0426] (iv) collecting the filtrate from the surfactant adsorber,

[0427] (v) contacting the filtrate to a chromatography medium;

[0428] (vi) collecting the plasma protein from the chromatography medium;

[0429] wherein the method produces a purified plasma protein preparation.

[0430] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0431] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0432] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0433] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0434] (iv) collecting the filtrate from the surfactant adsorber,(v) contacting the filtrate to a chromatography medium;

[0435] (vi) collecting the plasma protein from the chromatography medium;

[0436] wherein the method produces a purified plasma protein preparation.

[0437] In one example, the plasma protein is collected in the flow through from the chromatography medium. For example, the chromatography medium is operated in flow through mode. In another example, the plasma protein is collected in a post-load wash from the chromatography medium. For example, the chromatography medium is operated in bind-and-elute mode.

[0438] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0439] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0440] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0441] (iii) collecting the filtrate from the surfactant adsorber,

[0442] (iv) contacting the filtrate to a chromatography medium;

[0443] (v) collecting the flow through from the chromatography medium;

[0444] wherein the method produces a purified plasma protein preparation.

[0445] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0446] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO; and

[0447] (ii) a chromatography step comprising a chromatography medium;

[0448] wherein the method produces a purified plasma protein preparation.

[0449] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0450] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[0451] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0452] (iii) collecting the filtrate from the surfactant adsorber,

[0453] wherein the filtrate comprises a viral inactivated plasma protein preparation.The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0454] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[0455] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0456] (iii) collecting the filtrate from the surfactant adsorber,

[0457] (iv) contacting the filtrate to a chromatography medium;

[0458] (v) collecting the flow through from the chromatography medium;

[0459] wherein the method produces a purified plasma protein preparation.

[0460] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0461] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO; and

[0462] (ii) a chromatography step comprising a chromatography medium;

[0463] wherein the method produces a purified plasma protein preparation.

[0464] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0465] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[0466] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0467] (iii) collecting the filtrate from the surfactant adsorber,

[0468] wherein the filtrate comprises a viral inactivated plasma protein preparation.

[0469] The present disclosure further provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0470] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[0471] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and

[0472] (iii) collecting the filtrate from the surfactant adsorber,

[0473] (iv) contacting the filtrate to a chromatography medium;

[0474] (v) collecting the flow through from the chromatography medium;wherein the method produces a purified plasma protein preparation.

[0475] In one example, the one or more surfactant adsorber(s) is a carbonaceous material. In one example, the carbonaceous material comprises activated charcoal. In another example, the carbonaceous material comprises activated carbon.

[0476] In one example, the carbonaceous material is packed in a column, a cartridge, a sheet, a capsule, a pod or a bead. In another example, the carbonaceous material is packed in a column. For example, one or more columns. In another example, the carbonaceous material is packed in a cartridge. For example, one or more cartridges. In a further example, the carbonaceous material is packed in a sheet. For example, one or more sheets. In one example, the carbonaceous material is packed in a capsule. For example, one or more capsules. In another example, the carbonaceous material is packed in a pod. For example, one or more pods. In a further example, the carbonaceous material is packed in a bead. For example, one or more beads.

[0477] In one example, the carbonaceous material is impregnated into a porous material. In one example, the carbonaceous material is an activated carbon depth filter. In one example, the one or more surfactant adsorber(s) comprises spherical silica beads filled with a three-dimensional hydrophobic polymer or rigid, cross-linked, spherical agarose. In another example, the one or more surfactant adsorber(s) comprises spherical silica beads filled with a three-dimensional hydrophobic polymer. In a further example, the one or more surfactant adsorber(s) comprises rigid, cross-linked, spherical agarose.

[0478] In one example, the method comprises contacting the viral inactivated plasma sample or plasma fraction thereof to one surfactant adsorber after the viral inactivation step.

[0479] In one example, the method comprises contacting the viral inactivated plasma sample or plasma fraction thereof to two surfactant adsorbers after the viral inactivation step. For example, the method comprises contacting the viral inactivated plasma sample or plasma fraction thereof to a first and a second surfactant adsorber after the viral inactivation step.

[0480] In one example, the method comprises contacting the first surfactant adsorber with the viral inactivated plasma sample or plasma fraction thereof at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant.

[0481] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0482] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0483] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0484] (v) collecting a filtrate from the second surfactant adsorber,

[0485] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0486] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0487] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0488] (iii) collecting a first filtrate from the first surfactant adsorber;

[0489] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0490] (v) collecting a second filtrate from the second surfactant adsorber,

[0491] wherein the second filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0492] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0493] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0494] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0495] (iv) collecting a filtrate from the second surfactant adsorber,wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0496] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0497] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0498] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0499] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0500] (v) collecting a filtrate from the second surfactant adsorber,

[0501] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0502] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0503] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0504] (iii) collecting a first filtrate from the first surfactant adsorber;

[0505] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0506] (v) collecting a second filtrate from the second surfactant adsorber,

[0507] wherein the second filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0508] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0509] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0510] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0511] (iv) collecting a filtrate from the second surfactant adsorber,

[0512] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0513] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0514] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0515] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0516] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0517] (v) collecting a filtrate from the second surfactant adsorber,

[0518] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0519] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0520] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0521] (iii) collecting a first filtrate from the first surfactant adsorber;

[0522] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0523] (v) collecting a second filtrate from the second surfactant adsorber,

[0524] wherein the second filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0525] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0526] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0527] (iv) collecting a filtrate from the second surfactant adsorber,

[0528] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0529] In one example, the first surfactant adsorber and second surfactant adsorber are connected in series.

[0530] In one example, a first filtrate is applied directly from the first surfactant adsorber to the second surfactant adsorber. For example, the first filtrate is not collected from the first surfactant adsorber before contacting onto the second surfactant adsorber.

[0531] In one example, a first filtrate is collected from the first surfactant adsorber before contacting onto the second surfactant adsorber.

[0532] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0533] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0534] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0535] (iii) optionally collecting a first filtrate from the first surfactant adsorber;

[0536] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0537] (v) collecting a second filtrate from the second surfactant adsorber,

[0538] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0539] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0540] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0541] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0542] (iv) collecting a filtrate from the second surfactant adsorber,

[0543] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0544] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0545] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0546] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0547] (iii) collecting a first filtrate from the first surfactant adsorber;

[0548] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0549] (v) collecting a second filtrate from the second surfactant adsorber,

[0550] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0551] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0552] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[0553] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0554] (iii) optionally collecting a first filtrate from the first surfactant adsorber;

[0555] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0556] (v) collecting a second filtrate from the second surfactant adsorber,

[0557] wherein the second filtrate comprises the viral inactivated plasma protein preparation.The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0558] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[0559] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0560] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0561] (iv) collecting a filtrate from the second surfactant adsorber,

[0562] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0563] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0564] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[0565] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0566] (iii) collecting a first filtrate from the first surfactant adsorber;

[0567] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0568] (v) collecting a second filtrate from the second surfactant adsorber,

[0569] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0570] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0571] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[0572] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0573] (iii) optionally collecting a first filtrate from the first surfactant adsorber;(iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0574] (v) collecting a second filtrate from the second surfactant adsorber,

[0575] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0576] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0577] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[0578] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0579] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0580] (iv) collecting a filtrate from the second surfactant adsorber,

[0581] wherein the filtrate from the second surfactant adsorber comprises the viral inactivated plasma protein preparation.

[0582] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0583] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[0584] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0585] (iii) collecting a first filtrate from the first surfactant adsorber;

[0586] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0587] (v) collecting a second filtrate from the second surfactant adsorber,

[0588] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0589] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0590] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0591] (iii) collecting a first filtrate from the first surfactant adsorber;

[0592] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0593] (v) collecting a second filtrate from the second surfactant adsorber,

[0594] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0595] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0596] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;

[0597] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0598] (iii) collecting a first filtrate from the first surfactant adsorber;

[0599] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0600] (v) collecting a second filtrate from the second surfactant adsorber,

[0601] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0602] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0603] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[0604] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0605] (iii) collecting a first filtrate from the first surfactant adsorber;

[0606] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0607] (v) collecting a second filtrate from the second surfactant adsorber,

[0608] wherein the second filtrate comprises the viral inactivated plasma protein preparation.The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0609] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[0610] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0611] (iii) collecting a first filtrate from the first surfactant adsorber;

[0612] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0613] (v) collecting a second filtrate from the second surfactant adsorber,

[0614] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0615] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0616] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[0617] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0618] (iii) collecting a first filtrate from the first surfactant adsorber;

[0619] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0620] (v) collecting a second filtrate from the second surfactant adsorber,

[0621] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0622] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0623] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[0624] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0625] (iii) collecting a first filtrate from the first surfactant adsorber;(iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0626] (v) collecting a second filtrate from the second surfactant adsorber,

[0627] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0628] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0629] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0630] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0631] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0632] (iv) collecting a first filtrate from the first surfactant adsorber;

[0633] (v) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0634] (vi) collecting a second filtrate from the second surfactant adsorber,

[0635] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0636] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0637] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0638] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0639] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0640] (iv) collecting a first filtrate from the first surfactant adsorber;

[0641] (v) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and(vi) collecting a second filtrate from the second surfactant adsorber,

[0642] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0643] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0644] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0645] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0646] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0647] (iv) collecting a first filtrate from the first surfactant adsorber;

[0648] (v) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0649] (vi) collecting a second filtrate from the second surfactant adsorber,

[0650] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0651] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0652] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0653] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0654] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0655] (iv) collecting a first filtrate from the first surfactant adsorber;

[0656] (v) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0657] (vi) collecting a second filtrate from the second surfactant adsorber,

[0658] wherein the second filtrate comprises the viral inactivated plasma protein preparation.The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0659] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0660] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0661] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0662] (iv) collecting a first filtrate from the first surfactant adsorber;

[0663] (v) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0664] (vi) collecting a second filtrate from the second surfactant adsorber,

[0665] wherein the second filtrate comprises the viral inactivated plasma protein preparation.

[0666] The present disclosure provides a method of producing a viral inactivated plasma protein preparation from a plasma sample or a plasma fraction thereof, the method comprising:

[0667] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO and at a pH of between 4.0 and 7.0;

[0668] (ii) incubating the plasma sample or plasma fraction thereof with the surfactant for a period of between 5 minutes and 24 hours and at a temperature of between 10°C and 37°C;

[0669] (iii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0670] (iv) collecting a first filtrate from the first surfactant adsorber;

[0671] (v) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0672] (vi) collecting a second filtrate from the second surfactant adsorber,

[0673] wherein the second filtrate comprises the viral inactivated plasma protein preparation.In one example, the surfactant adsorber has a dynamic binding capacity of at least 200 g of surfactant / m2of adsorber. For example, the dynamic binding capacity of the surfactant adsorber is at least 250 g of surfactant / m2of adsorber.

[0674] In one example, the one or more surfactant adsorber(s) have a total surfactant binding capacity of at least 250 g surfactant / m2of adsorber. For example, the first and second surfactant adsorbers have a total surfactant binding capacity of at least 250 g surfactant / m2of adsorber. In one example, the one or more surfactant adsorber(s) have a total surfactant binding capacity of at least 300 g surfactant / m2of adsorber. For example, the first and second surfactant adsorbers have a total surfactant binding capacity of at least 300 g surfactant / m2of adsorber. In another example, the one or more surfactant adsorber(s) have a total surfactant binding capacity of at least 350 g surfactant / m2of adsorber. For example, the first and second surfactant adsorbers have a total surfactant binding capacity of at least 350 g surfactant / m2of adsorber.

[0675] In one example, the surfactant adsorber has a dynamic binding capacity of at least 100 g of surfactant / L of adsorber. For example, the surfactant adsorber has a dynamic binding capacity of at least 120 g of surfactant / L of adsorber.

[0676] In one example, the one or more surfactant adsorber(s) have a total surfactant binding capacity of at least 100 g surfactant / L of adsorber. For example, the first and second surfactant adsorbers have a total surfactant binding capacity of at least 100 g surfactant / L of adsorber. In one example, the one or more surfactant adsorber(s) have a total surfactant binding capacity of at least 120 g surfactant / m2of adsorber, or at least 150 g surfactant / m2of adsorber.

[0677] In one example, the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1:500 and 1:600. For example, the one or more surfactant adsorbers have a total surface area to plasma volume ratio of about 1 : 500, or about 1:510, or about 1:520, or about 1:530, or about 1:540, or about 1:550, or about 1:560, or about 1:570, or about 1:580, or about 1:590, or about 1:600. In one example, the one or more surfactant adsorbers have a total surface area to plasma volume ratio of between about 1:510 and 1 :560. In another example, the one or more surfactant adsorbers have a total surface area to plasma volume ratio of between about 1:510 and 1:520. In a further example, the one or more surfactant adsorbers have a total surface area to plasma volume ratio of between about 1:550 and 1:560.

[0678] In one example, the method is performed in large scale comprising at least 500L of the plasma or plasma fraction thereof. In one example, the method is performed using at least lOOOL of the plasma or plasma fraction thereof. In one example, the method is performed using at least 2500L of the plasma or plasma fraction thereof. In one example,the method is performed using at least 5000L of the plasma or plasma fraction thereof. In one example, the method is performed using at least 7500L of the plasma or plasma fraction thereof. For example, about 8000L of the plasma or plasma fraction thereof. In one example, the method is performed using at least 10000L of the plasma or plasma fraction thereof. In one example, the method is performed using at least 12500kg of the plasma or plasma fraction thereof. In one example, the method is performed using at least 15000kg of the plasma or plasma fraction thereof.

[0679] In one example, the method comprises using between about 8000L and 12000L of the plasma or plasma fraction thereof, wherein the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1 :500 and 1 :600.

[0680] In one example, the method comprises using about 8000L of the plasma or plasma fraction thereof, wherein the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1:500 and 1:600. For example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers having a total surface area of between 13 m2and 16 m2. In one example, the method comprises using about 8000L of the plasma or plasma fraction thereof, wherein the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1 :500 and 1:550. For example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers having a total surface area of between 14.5 m2and 16 m2. In another example, the method comprises using about 8000L of the plasma or plasma fraction thereof, wherein the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1:510 and 1:520. For example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers having a total surface area of between 15.4 m2and 15.7 m2. For example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area (m2) of about 15.6 m2. In one example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of between about 17.0 m2and 22.0 m2. In one example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of between about 17.7 m2and 22.0 m2. In one example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of about 17.7 m2. In another example, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of about 21.0 m2. In anotherexample, the method comprises using about 8000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of about 22.0 m2.

[0681] In one example, the method comprises using about 12000L of the plasma or plasma fraction thereof, wherein the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1:500 and 1:600. For example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers having a total surface area of between 20 m2and 24 m2. In one example, the method comprises using about 12000L of the plasma or plasma fraction thereof, wherein the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1 :530 and 1 :570. For example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers having a total surface area of between 21 m2and 23 m2. In another example, the method comprises using about 12000L of the plasma or plasma fraction thereof, wherein the one or more surfactant adsorbers have a total surface area (m2) to plasma volume (L) ratio of between 1:540 and 1:560. For example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers having a total surface area of between 21.4 m2and 22 m2. For example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area (m2) of about 21.6 m2. In one example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of between 17.0 m2and 22.0 m2.In one example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of between 17.7 m2and 22.0 m2. In one example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of about 17.7 m2. In another example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of about 21.0 m2. In another example, the method comprises using about 12000L of the plasma or plasma fraction thereof and one or more surfactant adsorbers with a total surface area of about 22.0 m2.

[0682] In one example, the one or more surfactant adsorbers have a total surface area of between 15 and 40 m2. In the one or more surfactant adsorbers have a total surface area of between 15 and 30 m2. For example, the one or more surfactant adsorbers have a total surface area of about 15 m2. For example, about 15.7 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 16.0 m2. In a further example, the one or more surfactant adsorber(s) have a total surface area of about 17.0m2. For example, about 17.7 m2. In another example, the one or more surfactant adsorbers have a total surface area of about 18 m2. For example, about 18.7 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 19.0 m2. For example, about 19.3 m2. In a further example, the one or more surfactant adsorbers have a total surface area of about 20 m2. For example, about 20.3 m2. For example, about 20.4 m2. In another example, the one or more surfactant adsorber(s) have a total surface area of about 21.0 m2. In one example, the one or more surfactant adsorbers have a total surface area of about 22 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 23.0 m2. For example, about 23.8 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 24.0 m2. For example, about 24.3 m2. For example, about 24.5 m2. In another example, the one or more surfactant adsorbers have a total surface area of about 25 m2. For example, about 25.1 m2. For example, about 25.9 m2. For example, about 26 m2. For example, about 26.4 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 27.0 m2. In a further example, the one or more surfactant adsorbers have a total surface area of about 28 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 29.0 m2. In one example, the one or more surfactant adsorbers have a total surface area of about 30 m2. For example, about 31 m2. For example, about 31.9 m2. In another example, the one or more surfactant adsorbers have a total surface area of about 32 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 33.0 m2. For example, about 33.6 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 34.0 m2. In a further example, the one or more surfactant adsorbers have a total surface area of about 35 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 36.0 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 37.0 m2. In one example, the one or more surfactant adsorbers have a total surface area of about 38 m2. In one example, the one or more surfactant adsorber(s) have a total surface area of about 39.0 m2. In another example, the one or more surfactant adsorbers have a total surface area of about 40 m2.

[0683] In one example, the one or more surfactant adsorbers have an equal filter area distribution. For example, each of the one or more surfactant adsorbers has the same filter area distribution. In another example, the first and second surfactant adsorbers have the same filter area distribution.

[0684] In one example, the one or more surfactant adsorbers have an unequal filter area distribution. For example, each of the one or more surfactant adsorbers has a different filter area distribution. In another example, the first and second surfactant adsorbers havedifferent filter area distributions. For example, the first surfactant adsorber has a greater filter area distribution compared to the second surfactant adsorber. In another example, the second surfactant adsorber has a greater filter area distribution compared to the first surfactant adsorber.

[0685] In one example, the one or more surfactant adsorbers have a 1:1 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 1 : 1 filter area distribution. In one example, the one or more surfactant adsorbers have a 1.5:1 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 1.5 : 1 filter area distribution. In one example, the one or more surfactant adsorbers have a 2:1 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 2:1 filter area distribution. In one example, the one or more surfactant adsorbers have a 2.5:1 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 2.5: 1 filter area distribution. In one example, the one or more surfactant adsorbers have a 3:1 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 3:1 filter area distribution. In one example, the one or more surfactant adsorbers have a 1:1.5 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 1:1.5 filter area distribution. In one example, the one or more surfactant adsorbers have a 1 :2 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 1:2 filter area distribution. In one example, the one or more surfactant adsorbers have a 1 :2.5 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 1:2.5 filter area distribution. In one example, the one or more surfactant adsorbers have a 1 :3 filter area distribution. For example, the method comprises a first and second surfactant adsorber, wherein the first and second surfactant adsorbers have a 1:3 filter area distribution.

[0686] In one example, the first surfactant adsorber has a filter area distribution of between 8 m2and 20 m2and the second surfactant adsorber has a filter area distribution of between 3 m2and 8 m2. In another example, the first surfactant adsorber has a filter area distribution of between 10 m2and 16 m2and the second surfactant adsorber has a filter area distribution of between 4 m2and 6 m2. In a further example, the first surfactant adsorber has a filter area distribution of between 10.5 m2and 16 m2and the secondsurfactant adsorber has a filter area distribution of between 4.5 m2and 6 m2. For example, example, the first surfactant adsorber has a filter area distribution of about 10.8 m2and the second surfactant adsorber has a filter area distribution of about 4.8 m2. In another example, the first surfactant adsorber has a filter area distribution of about 15.6 m2and the second surfactant adsorber has a filter area distribution of about 6.0 m2. In another example, the first surfactant adsorber has a filter area distribution of about 15.0 m2and the second surfactant adsorber has a filter area distribution of about 6.0 m2.

[0687] In one example, the surfactant adsorber removes at least 95% of the surfactant from the viral inactivated plasma sample or plasma fraction thereof. In another example, the surfactant adsorber removes at least 96% of the surfactant from the viral inactivated plasma sample or plasma fraction thereof. In a further example, the surfactant adsorber removes at least 97% of the surfactant from the viral inactivated plasma sample or plasma fraction thereof. In one example, the surfactant adsorber removes at least 98% of the surfactant from the viral inactivated plasma sample or plasma fraction thereof. In another example, the surfactant adsorber removes at least 99% of the surfactant from the viral inactivated plasma sample or plasma fraction thereof.

[0688] In one example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 5 ppm after contacting the one or more surfactant adsorbers. In another example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 4.5 ppm after contacting the one or more surfactant adsorbers. In a further example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 4 ppm after contacting the one or more surfactant adsorbers. In one example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 3.5 ppm after contacting the one or more surfactant adsorbers. In another example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 3 ppm after contacting the one or more surfactant adsorbers. In a further example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 2.5 ppm after contacting the one or more surfactant adsorbers. In one example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 2 ppm after contacting the one or more surfactant adsorbers. In another example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 1.5 ppm after contacting the one or more surfactant adsorbers. In a further example, the surfactant concentration in the viral inactivated plasma sample or plasma fraction thereof is less than 1 ppm after contacting the one or more surfactant adsorbers. In one example, the surfactantconcentration in the viral inactivated plasma sample or plasma fraction thereof is less than 0.5 ppm after contacting the one or more surfactant adsorbers.

[0689] In one example, the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers selected from the group consisting of a phosphate buffer, a sodium citrate buffer, a 2-(N-morpholino)ethanesulfonic acid buffer, an acetic acid buffer, a Bis-tris buffer and a L-histidine buffer. In one example, the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers comprising a phosphate buffer. In another example, the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers comprising a sodium citrate buffer. In a further example, the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers comprising a 2-(N-morpholino)ethanesulfonic acid buffer. In one example, the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers comprising an acetic acid buffer. In a further example, the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers comprising a Bis-tris buffer. In another example, the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers comprising a L-histidine buffer.

[0690] In one example, the surfactant adsorber post-load wash buffer is at a pH in the range of pH 4.0 to 7.0. In one example, the surfactant adsorber post-load wash buffer is at a pH in the range of pH 4.0 to 6.5. In one example, the surfactant adsorber post-load wash buffer is at a pH in the range of pH 4.0 to 6.0. In another example, the surfactant adsorber post-load wash buffer is at pH 4.0. In another example, the surfactant adsorber post-load wash buffer is at pH 4.5. In a further example, the surfactant adsorber postload wash buffer is at pH 5.0. In one example, the surfactant adsorber post -load wash buffer is at pH 5.5. In another example, the surfactant adsorber post-load wash buffer is at pH 6.0.

[0691] In one example, the surfactant adsorber post-load wash buffer comprises a phosphate buffer at a pH in the range of 4.0 to 6.0. In another example, the surfactant adsorber post-load wash buffer comprises a phosphate buffer at pH 4.0. In another example, the surfactant adsorber post-load wash buffer comprises a phosphate buffer at pH 4.5. In a further example, the surfactant adsorber post-load wash buffer comprises a phosphate buffer at pH 5.0. In one example, the surfactant adsorber post-load wash buffer comprises a phosphate buffer at pH 5.5. In another example, the surfactant adsorber postload wash buffer comprises a phosphate buffer at pH 6.0.In one example, the method further comprises a chromatography step comprising a chromatography medium after the one or more surfactant adsorber(s).

[0692] In one example, the chromatography step is operated in bind-and-elute mode. In another example, the chromatography step is operated in flow through mode.

[0693] In one example, the chromatography medium is an anion exchange chromatography medium.

[0694] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0695] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0696] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0697] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0698] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0699] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0700] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0701] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0702] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0703] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0704] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0705] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0706] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0707] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0708] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0709] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0710] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0711] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0712] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0713] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0714] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0715] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0716] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0717] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0718] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),(iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0719] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0720] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0721] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0722] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0723] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0724] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0725] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0726] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0727] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0728] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0729] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0730] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0731] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0732] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0733] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0734] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0735] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0736] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0737] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0738] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0739] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0740] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0741] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0742] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0743] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0744] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0745] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0746] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0747] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0748] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0749] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0750] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0751] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0752] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0753] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0754] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0755] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0756] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0757] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0758] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0759] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0760] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0761] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0762] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0763] (iii) optionally collecting a filtrate from the first surfactant adsorber;(iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0764] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0765] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0766] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0767] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0768] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0769] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0770] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0771] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0772] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0773] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0774] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0775] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0776] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0777] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and(vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0778] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0779] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0780] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0781] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0782] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0783] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0784] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0785] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0786] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0787] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0788] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0789] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0790] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0791] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0792] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0793] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0794] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0795] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0796] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0797] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0798] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0799] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0800] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0801] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0802] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0803] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0804] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and(iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0805] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0806] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0807] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0808] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0809] (iii) collecting a first filtrate from the first surfactant adsorber;

[0810] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0811] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0812] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0813] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0814] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.50% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0815] (iii) collecting a first filtrate from the first surfactant adsorber;

[0816] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0817] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0818] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0819] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.40% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0820] (iii) collecting a first filtrate from the first surfactant adsorber;

[0821] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0822] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0823] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0824] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0825] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.20% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0826] (iii) collecting a first filtrate from the first surfactant adsorber;

[0827] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0828] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0829] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0830] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0831] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.32% (w / w);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0832] (iii) collecting a first filtrate from the first surfactant adsorber;

[0833] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0834] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0835] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0836] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0837] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.30% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0838] (iii) collecting a first filtrate from the first surfactant adsorber;

[0839] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0840] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0841] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0842] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0843] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.22% and 0.28% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0844] (iii) collecting a first filtrate from the first surfactant adsorber;

[0845] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and(v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0846] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0847] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0848] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0849] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0850] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0851] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0852] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0853] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0854] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0855] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0856] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0857] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0858] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0859] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0860] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0861] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0862] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0863] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0864] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0865] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0866] (iii) collecting a first filtrate from the first surfactant adsorber;

[0867] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0868] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0869] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0870] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0871] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[0872] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[0873] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0874] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0875] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0876] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0877] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0878] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0879] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0880] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0881] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0882] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0883] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0884] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0885] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0886] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0887] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v);(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant,

[0888] (iii) collecting a first filtrate from the first surfactant adsorber;

[0889] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber; and

[0890] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0891] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0892] In one example, the anion exchange chromatography step comprises using a strong anion exchange resin operated in flow-through mode.

[0893] In one example, the strong anion exchange resin comprises a matrix consisting of a poly(styrene-divinylbenzene) matrix. In another example, the strong anion exchange resin comprises a quaternized polyethyleneimine functional group. In a further example, the strong anion exchange resin comprises a quaternary amine functional group.

[0894] In one example, the anion exchange chromatography step comprises a post-load wash buffer selected from the group consisting of a phosphate buffer, a sodium citrate buffer, a 2-(N-morpholino)ethanesulfonic acid buffer, an acetic acid buffer, a Bis-tris buffer and a L-histidine buffer. In one example, the anion exchange chromatography step comprises a post-load wash buffer comprising a phosphate buffer. In another example, the anion exchange chromatography step comprises a post-load wash buffer comprising a sodium citrate buffer. In a further example, the anion exchange chromatography step comprises a post-load wash buffer comprising a 2-(N-morpholino)ethanesulfonic acid buffer. In one example, the anion exchange chromatography step comprises a post-load wash buffer comprising an acetic acid buffer. In a further example, the anion exchange chromatography step comprises a post-load wash buffer comprising a Bis-tris buffer. In another example, the anion exchange chromatography step comprises a post-load wash buffer comprising a L-histidine buffer.

[0895] In one example, the anion exchange chromatography post-load wash buffer is at a pH in the range of pH 5.5 to 7.0. For example, the anion exchange chromatography post-load wash buffer is at a pH in the range of pH 5.8 to 6.6. In another example, the anion exchange chromatography post-load wash buffer is at pH 5.8. In another example, the anion exchange chromatography post-load wash buffer is at pH 6.0. In a further example, the anion exchange chromatography post-load wash buffer is at pH 6.2. In oneexample, the anion exchange chromatography post-load wash buffer is at pH 6.4. In another example, the anion exchange chromatography post-load wash buffer is at pH 6.6.

[0896] In one example, the anion exchange chromatography post-load wash buffer comprises a phosphate buffer at a pH in the range of 5.5 to 7.0. For example, in the pH range of 5.8 to 6.6. In another example, the anion exchange chromatography post-load wash buffer comprises a phosphate buffer at pH 5.8. In another example, the anion exchange chromatography post-load wash buffer comprises a phosphate buffer at pH 6.0. In a further example, the anion exchange chromatography post-load wash buffer comprises a phosphate buffer at pH 6.2. In one example, the anion exchange chromatography post-load wash buffer comprises a phosphate buffer at pH 6.4. In another example, the anion exchange chromatography post-load wash buffer comprises a phosphate buffer at pH 6.6.

[0897] In one example, the anion exchange chromatography post-load wash buffer comprises sodium chloride at a concentration of between 0 mM and 50 mM. In another example, the anion exchange chromatography post-load wash buffer comprises 0 mM sodium chloride. In a further example, the anion exchange chromatography post-load wash buffer comprises 10 mM sodium chloride. In one example, the anion exchange chromatography post-load wash buffer comprises 20 mM sodium chloride. In another example, the anion exchange chromatography post-load wash buffer comprises 30 mM sodium chloride. In a further example, the anion exchange chromatography post-load wash buffer comprises 40 mM sodium chloride. In one example, the anion exchange chromatography post-load wash buffer comprises 50 mM sodium chloride.

[0898] In one example, the method further comprises adjusting the pH of the viral inactivated plasma protein preparation prior to loading onto the chromatography medium.

[0899] In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of between 6.0 and 7.0. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of about 6.0. In a further example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of about 6.1. In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.2. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.3. In a further example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.4. In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.5. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.6. In a further example, the pH of the viral inactivated plasma protein preparation isadjusted to a pH of 6.7. In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.8. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.9. In a further example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 7.0.

[0900] In one example, the pH of the viral inactivated plasma protein preparation is adjusted with Tri s(hydroxymethyl)aminom ethane (i.e., Tris). For example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of between 6.0 and 7.0 with Tris. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of about 6.0 with Tris. In a further example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of about 6.1 with Tris. In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.2 with Tris. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.3 with Tris. In a further example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.4 with Tris. In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.5 with Tris. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.6 with Tris. In a further example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.7 with Tris. In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.8 with Tris. In another example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.9 with Tris. In a further example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 7.0 with Tris.

[0901] In one example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.5 with IM Tris.

[0902] In one example, the viral inactivated plasma protein preparation is loaded onto the anion exchange chromatography resin at a pH of 6.50.

[0903] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0904] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0905] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[0906] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[0907] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium,wherein the method produces a purified plasma protein preparation.

[0908] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0909] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;

[0910] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[0911] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[0912] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0913] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0914] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;

[0915] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[0916] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[0917] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0918] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0919] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[0920] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[0921] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[0922] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0923] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[0924] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[0925] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[0926] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0927] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0928] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[0929] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[0930] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[0931] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0932] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0933] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[0934] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[0935] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[0936] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0937] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0938] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0939] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0940] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0941] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0942] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0943] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0944] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0945] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;

[0946] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0947] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0948] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0949] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0950] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0951] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0952] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0953] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;

[0954] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0955] (iii) optionally collecting a filtrate from the first surfactant adsorber;(iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0956] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0957] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0958] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0959] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0960] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[0961] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0962] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0963] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0964] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0965] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0966] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0967] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0968] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[0969] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0970] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0971] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0972] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;(vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0973] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0974] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0975] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[0976] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0977] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0978] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0979] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0980] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0981] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0982] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0983] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[0984] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0985] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[0986] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0987] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0988] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0989] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0990] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[0991] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0992] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[0993] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[0994] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[0995] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[0996] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[0997] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;

[0998] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[0999] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1000] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1001] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1002] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1003] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1004] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1005] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1006] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1007] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1008] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1009] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1010] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[1011] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1012] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1013] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1014] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1015] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1016] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1017] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[1018] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1019] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and(iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1020] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1021] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1022] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1023] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[1024] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1025] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1026] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1027] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1028] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1029] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1030] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[1031] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1032] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1033] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1034] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1035] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1036] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / w) TDAO;

[1037] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1038] (iii) collecting a first filtrate from the first surfactant adsorber;

[1039] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1040] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1041] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1042] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1043] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.50% (w / w) TDAO;

[1044] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1045] (iii) collecting a first filtrate from the first surfactant adsorber;

[1046] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1047] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1048] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1049] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1050] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.40% (w / w) TDAO;(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1051] (iii) collecting a first filtrate from the first surfactant adsorber;

[1052] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1053] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1054] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1055] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1056] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.20% and 0.30% (w / w) TDAO;

[1057] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1058] (iii) collecting a first filtrate from the first surfactant adsorber;

[1059] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1060] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1061] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1062] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1063] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.32% (w / w) TDAO;

[1064] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1065] (iii) collecting a first filtrate from the first surfactant adsorber;

[1066] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and(v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1067] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1068] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1069] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.30% (w / w) TDAO;

[1070] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1071] (iii) collecting a first filtrate from the first surfactant adsorber;

[1072] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1073] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1074] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1075] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1076] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.22% and 0.28% (w / w) TDAO;

[1077] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1078] (iii) collecting a first filtrate from the first surfactant adsorber;

[1079] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1080] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1081] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1082] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[1083] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[1084] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[1085] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1086] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1087] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[1088] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1089] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1090] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1091] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1092] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1093] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1094] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1095] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[1096] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1097] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and(iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1098] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1099] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1100] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1101] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (w / v) TDAO;

[1102] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1103] (iii) collecting a first filtrate from the first surfactant adsorber;

[1104] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1105] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1106] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1107] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1108] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[1109] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) comprising activated charcoal,

[1110] (iii) collecting a filtrate comprising the viral inactivated plasma protein preparation from the one or more surfactant adsorber(s);

[1111] (iv) contacting the filtrate to an anion exchange chromatography medium, and (v) collecting the filtrate from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1112] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1113] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1114] (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1115] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1116] (v) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1117] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1118] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1119] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1120] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[1121] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1122] (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1123] (iv) collecting a filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1124] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1125] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1126] The present disclosure provides a method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:

[1127] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with between 0.01% and 0.5% (v / v) TDAO;

[1128] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,

[1129] (iii) collecting a first filtrate from the first surfactant adsorber;(iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1130] (v) collecting a second filtrate comprising the viral inactivated plasma protein preparation from the second surfactant adsorber;

[1131] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified plasma protein preparation.

[1132] In one example, at least 75% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. For example, 75%, or 76%, or 77%, or 78%, or 79% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 76% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 77% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 78% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In another example, 79% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation.

[1133] In one example, at least 80% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. For example, 80%, or 81%, or 82%, or 83%, or 84% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 80% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 81% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 82% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 83% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In another example, 84% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation.

[1134] In one example, at least 85% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. For example, 85%, or 86%, or 87%, or 88%, or 89% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 85% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 86% of the plasma protein from theplasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 87% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 88% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In another example, 89% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation.

[1135] In one example, at least 90% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. For example, 90%, or 91%, or 92%, or 93%, or 94% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 90% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 91% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 92% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 93% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In another example, 94% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation.

[1136] In one example, at least 95% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. For example, 95%, or 96%, or 97%, or 98%, or 99% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 95% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 96% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 97% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In one example, 98% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation. In another example, 99% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation.

[1137] In one example, the plasma protein in the purified plasma protein preparation has a purity of at least 95%. In another example, the plasma protein in the purified plasma protein preparation has a purity of at least 96%. In a further example, the plasma protein in the purified plasma protein preparation has a purity of at least 97%. In one example, the plasma protein in the purified plasma protein preparation has a purity of at least 98%.In another example, the plasma protein in the purified plasma protein preparation has a purity of at least 99%.

[1138] In one example, the method is performed at large scale. For example, the method is performed on an industrial or a commercial scale. Methods of performing on an industrial or a commercial scale will be apparent to a skilled person and / or described herein. In one example, the method performed on an industrial scale comprises purification of the plasma protein from the plasma or fraction thereof. For example, the method performed on an industrial scale comprises large scale purification of IgG from the plasma or fraction thereof.

[1139] In one example, large scale purification of IgG is performed using at least 500kg of the plasma or fraction thereof. For example, large scale purification of IgG is performed using between 500kg to 1000kg, or 1000kg to 2500kg, or 2500kg to 5000kg, or 5000kg to 7500kg, or 7500kg, or 10000kg, or 10000kg to 12500kg, or 12500kg to 15000kg of the plasma or fraction thereof. In one example, large scale purification of IgG is performed using at least 1000kg, or 2500kg, or 5000kg, or 7500kg, or 10000kg, or 12500kg, or 15000kg of the plasma of fraction thereof. In one example, large scale purification of IgG is performed using at least 1000kg of the plasma of fraction thereof. In one example, large scale purification of IgG is performed using at least 2500kg of the plasma of fraction thereof. In one example, large scale purification of IgG is performed using at least 5000kg of the plasma of fraction thereof. In one example, large scale purification of IgG is performed using at least 7500kg of the plasma of fraction thereof. In one example, large scale purification of IgG is performed using at least 10000kg of the plasma of fraction thereof. In one example, large scale purification of IgG is performed using at least 12500kg of the plasma of fraction thereof. In one example, large scale purification of IgG is performed using at least 15000kg of the plasma of fraction thereof.

[1140] In one example, the plasma protein is selected from the group consisting of an immunoglobulin (IgG), a RhD immunoglobulin protein product, an apolipoprotein Al, an albumin, a protease, plasminogen, an alpha- 1- antitrypsin, a fibrinogen, a von Willebrand factor, an activated clotting factor, a prekallikrein activator (PKA), a prothrombin complex, a Cl esterase inhibitor, a protein C, an anti-thrombin III, alpha acid glycoprotein, haptoglobin, hemopexin, transferrin, Factor H, a coagulation factor, an oligomeric form or degradation product of any of the foregoing and combinations thereof.

[1141] In one example, the plasma protein is an IgG.

[1142] In one example, the plasma protein is a RhD immunoglobulin protein productIn one example, the plasma protein is an apolipoprotein Al.

[1143] In one example, the plasma protein is an albumin.

[1144] In one example, the plasma protein is a protease. For example, a serine protease or a plasmin.

[1145] In one example, the plasma protein is plasminogen.

[1146] In one example, the plasma protein is an alpha- 1- antitrypsin.

[1147] In one example, the plasma protein is a fibrinogen.

[1148] In one example, the plasma protein is a von Willebrand factor.

[1149] In one example, the plasma protein is an activated clotting factor.

[1150] In one example, the plasma protein is a prekallikrein activator (PKA).

[1151] In one example, the plasma protein is a prothrombin complex.

[1152] In one example, the plasma protein is a Cl esterase inhibitor.

[1153] In one example, the plasma protein is a protein C.

[1154] In one example, the plasma protein is an anti-thrombin III.

[1155] In one example, the plasma protein is alpha acid glycoprotein.

[1156] In one example, the plasma protein is haptoglobin.

[1157] In one example, the plasma protein is hemopexin.

[1158] In one example, the plasma protein is transferrin.

[1159] In one example, the plasma protein is Factor H.

[1160] In one example, the plasma protein is a coagulation factor. For example, the coagulation factor is factor Xa, factor VII, factor VIII, a factor IX, factor XII, factor XIII and / or factor XI. In one example, the coagulation factor is factor Xa. In another example, the coagulation factor is factor VII. In a further example, the coagulation factor is factor VIII. In one example, the coagulation factor is factor IX. In another example, the coagulation factor is factor XI. In a further example, the coagulation factor is factor XII. In one example, the coagulation factor is factor XIII.

[1161] In one example, the plasma protein is an oligomeric form or degradation product of any of the foregoing plasma proteins.

[1162] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1163] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[1164] (iii) collecting a filtrate from the one or more surfactant adsorber(s);(iv) contacting the filtrate from the one or more surfactant adsorber(s) to a chromatography medium, and

[1165] (v) collecting the flow through from the chromatography medium,

[1166] wherein the method produces a purified IgG preparation.

[1167] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1168] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.01% and 0.5% (w / w) TDAO;

[1169] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1170] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to a chromatography medium, and

[1171] (v) collecting the flow through from the chromatography medium,

[1172] wherein the method produces a purified IgG preparation.

[1173] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1174] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.01% and 0.5% (w / w) TDAO;

[1175] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1176] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1177] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1178] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1179] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / w) TDAO;

[1180] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1181] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1182] (v) collecting the flow through from the anion exchange chromatography medium,wherein the method produces a purified IgG preparation.

[1183] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1184] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.20% and 0.30% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1185] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1186] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1187] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1188] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.32% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1189] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1190] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1191] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1192] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.30% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1193] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1194] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1195] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.28% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1196] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1197] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1198] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1199] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / w) TDAO;

[1200] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1201] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1202] (v) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1203] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1204] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1205] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1206] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.20% and 0.30% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1207] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and(v) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1208] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1209] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1210] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1211] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.32% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1212] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1213] (v) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1214] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1215] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1216] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1217] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.30% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1218] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1219] (v) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1220] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and(vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1221] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1222] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.28% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1223] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1224] (v) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1225] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1226] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1227] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1228] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / w) TDAO;

[1229] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1230] (iv) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1231] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1232] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1233] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.20% and 0.30% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1234] (iv) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1235] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1236] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1237] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1238] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.32% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1239] (iv) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1240] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1241] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1242] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1243] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.30% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,(iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1244] (iv) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1245] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1246] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1247] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1248] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.28% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1249] (iv) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1250] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1251] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1252] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1253] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / w) TDAO;

[1254] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) collecting a first filtrate from the first surfactant adsorber;

[1255] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1256] (v) collecting a second filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1257] (vi) contacting the second filtrate to an anion exchange chromatography medium, and(vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1258] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1259] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.20% and 0.30% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) collecting a first filtrate from the first surfactant adsorber;

[1260] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1261] (v) collecting a second filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1262] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1263] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1264] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.32% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) collecting a first filtrate from the first surfactant adsorber;

[1265] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1266] (v) collecting a second filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1267] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1268] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1269] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.30% (w / w) TDAO;(ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) collecting a first filtrate from the first surfactant adsorber;

[1270] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1271] (v) collecting a second filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1272] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1273] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1274] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.22% and 0.28% (w / w) TDAO; (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) collecting a first filtrate from the first surfactant adsorber;

[1275] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1276] (v) collecting a second filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1277] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1278] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1279] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[1280] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1281] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to a chromatography medium, and

[1282] (v) collecting the flow through from the chromatography medium,wherein the method produces a purified IgG preparation.

[1283] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1284] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.01% and 0.5% (w / v) TDAO;

[1285] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1286] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to a chromatography medium, and

[1287] (v) collecting the flow through from the chromatography medium,

[1288] wherein the method produces a purified IgG preparation.

[1289] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1290] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.01% and 0.5% (w / v) TDAO;

[1291] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1292] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1293] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1294] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1295] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / v) TDAO;

[1296] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1297] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1298] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1299] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:(i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / v) TDAO;

[1300] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1301] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1302] (v) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1303] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1304] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1305] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1306] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / v) TDAO;

[1307] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1308] (iv) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1309] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1310] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1311] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1312] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (w / v) TDAO;

[1313] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO,(iii) collecting a first filtrate from the first surfactant adsorber;

[1314] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1315] (v) collecting a second filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1316] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1317] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1318] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (v / v); (ii) contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s),

[1319] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1320] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to a chromatography medium, and

[1321] (v) collecting the flow through from the chromatography medium,

[1322] wherein the method produces a purified IgG preparation.

[1323] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1324] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.01% and 0.5% (v / v) TDAO;

[1325] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1326] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to a chromatography medium, and

[1327] (v) collecting the flow through from the chromatography medium,

[1328] wherein the method produces a purified IgG preparation.

[1329] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1330] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.01% and 0.5% (v / v) TDAO;

[1331] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal,Ill

[1332] (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1333] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1334] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1335] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1336] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (v / v) TDAO;

[1337] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to one or more surfactant adsorber(s) comprising activated charcoal, (iii) collecting a filtrate from the one or more surfactant adsorber(s);

[1338] (iv) contacting the filtrate from the one or more surfactant adsorber(s) to an anion exchange chromatography medium, and

[1339] (v) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1340] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1341] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (v / v) TDAO;

[1342] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) optionally collecting a filtrate from the first surfactant adsorber;

[1343] (iv) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1344] (v) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1345] (vi) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1346] (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1347] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1348] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (v / v) TDAO;(ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) contacting the filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1349] (iv) collecting a filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1350] (v) contacting the filtrate from the second surfactant adsorber to an anion exchange chromatography medium, and

[1351] (vi) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1352] The present disclosure provides a method of purifying an immunoglobulin G (IgG) from a plasma sample or a plasma fraction thereof, the method comprising:

[1353] (i) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof comprising the IgG with between 0.2% and 0.4% (v / v) TDAO;

[1354] (ii) contacting the viral inactivated plasma sample or plasma fraction thereof comprising the IgG to a first surfactant adsorber comprising activated charcoal at a concentration above the surfactant adsorber’s dynamic binding capacity for the TDAO, (iii) collecting a first filtrate from the first surfactant adsorber;

[1355] (iv) contacting the first filtrate from the first surfactant adsorber with a second surfactant adsorber comprising activated charcoal; and

[1356] (v) collecting a second filtrate comprising the viral inactivated IgG preparation from the second surfactant adsorber;

[1357] (vi) contacting the second filtrate to an anion exchange chromatography medium, and (vii) collecting the flow through from the anion exchange chromatography medium, wherein the method produces a purified IgG preparation.

[1358] In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is less than 20 ppm. In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is less than 10 ppm. In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is less than 5 ppm. In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is less than 0.5ppm.

[1359] In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is less than 20 ppm. In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is less than 10 ppm. In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is lessthan 5 ppm. In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber less than 0.5ppm.

[1360] In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is between 50 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is between 20 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is between 10 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is between 5 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the one or more surfactant adsorber(s) is between 0.5 and O.OOlppm.

[1361] In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is between 50 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is between 20 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is between 10 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is between 5 ppm and 0.001 ppm. In one example, the concentration of surfactant in the filtrate from the second surfactant adsorber is between 0.5 and O.OOlppm.

[1362] In one example, the level of one or more impurities in the purified plasma preparation is reduced compared to the plasma sample or fraction thereof.

[1363] In one example, the one or more impurities is selected from the group consisting of an IgA, an IgM, a RhD immunoglobulin protein product, an apolipoprotein Al, an albumin, a protease, plasminogen, an alpha-1- antitrypsin, a fibrinogen, a von Willebrand factor, an activated clotting factor, a prekallikrein activator (PKA), a prothrombin complex, a Cl esterase inhibitor, a protein C, an anti-thrombin III, alpha acid glycoprotein, haptoglobin, hemopexin, transferrin, Factor H, a coagulation factor, a virus, an endotoxin, an oligomeric form or degradation product of any of the foregoing and combinations thereof.

[1364] In one example, the impurity is an IgA. In a further example, the impurity is an IgM. In one example, the impurity is a RhD immunoglobulin protein product.

[1365] In one example, the impurity is an apolipoprotein Al.

[1366] In one example, the impurity is an albumin.

[1367] In one example, the impurity is a protease. For example, a serine protease or a plasmin.

[1368] In one example, the impurity is plasminogen.In one example, the impurity is an alpha-1- antitrypsin.

[1369] In one example, the impurity is a fibrinogen.

[1370] In one example, the impurity is a von Willebrand factor.

[1371] In one example, the impurity is an activated clotting factor.

[1372] In one example, the impurity is a prekallikrein activator (PKA).

[1373] In one example, the impurity is a prothrombin complex.

[1374] In one example, the impurity is a Cl esterase inhibitor.

[1375] In one example, the impurity is a protein C.

[1376] In one example, the impurity is an anti-thrombin III.

[1377] In one example, the impurity is alpha acid glycoprotein.

[1378] In one example, the impurity is haptoglobin.

[1379] In one example, the impurity is hemopexin.

[1380] In one example, the impurity is transferrin.

[1381] In one example, the impurity is Factor H.

[1382] In one example, the impurity is a coagulation factor. For example, the coagulation factor is factor Xa, factor VII, factor VIII, a factor IX, factor XII, factor XIII and / or factor XI. In one example, the coagulation factor is factor Xa. In another example, the coagulation factor is factor VII. In a further example, the coagulation factor is factor VIII. In one example, the coagulation factor is factor IX. In another example, the coagulation factor is factor XI. In a further example, the coagulation factor is factor XII. In one example, the coagulation factor is factor XIII.

[1383] In one example, the impurity is an oligomeric form or degradation product of any of the foregoing plasma proteins.

[1384] In one example of any method described herein, the level of one or more viruses in the purified plasma preparation is reduced compared to the plasma sample or fraction thereof.

[1385] In one example, the level of one or more viruses in the purified plasma preparation is reduced by at least >4.0 Logw reduction factor (LRF) compared to the plasma sample or fraction thereof. For example, the level of one or more viruses in the purified plasma preparation is reduced by at least >4.1, >4.2, >4.3, >4.4, >4.5, >4.6, >4.7, >4.8 or >4.9 LRF. In another example, the level of one or more viruses in the purified plasma preparation is reduced by at least >5.0 LRF compared to the plasma sample or fraction thereof. For example, the level of one or more viruses in the purified plasma preparation is reduced by at least >5.1, >5.2, >5.3, >5.4, >5.5, >5.6, >5.7, >5.8 or >5.9 LRF. In another example, the level of one or more viruses in the purified plasma preparation is reduced by at least >6.0 LRF compared to the plasma sample or fraction thereof. Forexample, the level of one or more viruses in the purified plasma preparation is reduced by at least >6.1, >6.2, >6.3, >6.4, >6.5, >6.6, >6.7, >6.8 or >6.9 LRF.

[1386] In one example, the method of the disclosure achieves a Logw reduction factor (LRF) of one or more viruses in the purified plasma preparation of at least >4.0 Logio compared to the plasma sample or fraction thereof. For example, the method of the disclosure achieves a LRF of one or more viruses in the purified plasma preparation of at least >4.1, >4.2, >4.3, >4.4, >4.5, >4.6, >4.7, >4.8 or >4.9 Logio compared to the plasma sample or fraction thereof. In another example, the method of the disclosure achieves a LRF of one or more viruses in the purified plasma preparation of at least >5.0 Logio compared to the plasma sample or fraction thereof. For example, the method of the disclosure achieves a LRF of one or more viruses in the purified plasma preparation of at least >5.1, >5.2, >5.3, >5.4, >5.5, >5.6, >5.7, >5.8 or >5.9 Logio compared to the plasma sample or fraction thereof. In another example, the method of the disclosure achieves a LRF of one or more viruses in the purified plasma preparation of at least >6 Logio compared to the plasma sample or fraction thereof. For example, the method of the disclosure achieves a LRF of one or more viruses in the...

Claims

CLAIMS1. A method of purifying a plasma protein from a plasma sample or a plasma fraction thereof, the method comprising:(A) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w), or between 0.01% and 0.5% (w / v), or between 0.01% and 0.5% (v / v); and a chromatography step comprising a chromatography medium, wherein the method produces a purified plasma protein preparation; or(B) a viral inactivation step comprising contacting the plasma sample or plasma fraction thereof with a surfactant at a concentration of between 0.01% and 0.5% (w / w) , or between 0.01% and 0.5% (w / v), or between 0.01% and 0.5% (v / v); contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s); and collecting the filtrate from the surfactant adsorber, wherein the filtrate comprises a viral inactivated plasma protein preparation.

2. The method of claim 1A, wherein the method further comprises contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) after the viral inactivation step, and collecting the filtrate from the surfactant adsorber, wherein the filtrate comprises a viral inactivated plasma protein preparation.

3. The method of claims 1 or 2, wherein the plasma sample or plasma fraction thereof is an affinity chromatography eluate.

4. The method of any one of claims 1 to 3, wherein the method comprises contacting the plasma sample or plasma fraction thereof with:(i) between 0.2 and 0.5% (w / w), or between 0.2 and 0.5% (w / v), or between 0.2 and 0.5% (v / v) of the surfactant;(ii) between 0.22 and 0.4% (w / w), or between 0.22 and 0.4% (w / v), or between 0.22 and 0.4% (v / v) of the surfactant;(iii)between 0.22 and 0.32% (w / w), or between 0.22 and 0.32% (w / v), or between 0.22 and 0.32% (v / v);(iv)between 0.22 and 0.3% (w / w), or between 0.22 and 0.3% (w / v), or between 0.22 and 0.3% (v / v) of the surfactant;(v) between 0.22 and 0.28% (w / w), or between 0.22 and 0.28% (w / v), or between 0.22 and 0.28% (v / v); or(vi)about 0.28% (w / w), or about 0.28% (w / v), or about 0.28% (v / v) of the surfactant.

5. The method of any one of claims 1 to 4, wherein the method comprises incubating the plasma sample or plasma fraction thereof with the surfactant for:(A) a period of:(i) at least 5 minutes;(ii) at least 20 minutes;(iii)at least 1 hour;(iv)at least 4 hours; or(v) between 4 and 15 hours; and / or(B) at a pH of:(i) between 4.0 and 6.0; or(ii) about 5.0.

6. The method of any one of claims 1 to 5, wherein the surfactant is Myristyldimethylamine-N-oxide (TDAO), optionally wherein the surfactant comprises 0.2 to 0.3% (w / w) TDAO, or 0.2 to 0.3% (w / v) TDAO, or 0.2 to 0.3% (v / v) TDAO, or 0.22 to 0.32% (w / w) TDAO, or 0.22 to 0.32% (w / v) TDAO, or 0.22 to 0.32% (v / v) TDAO.

7. The method of any one of claims IB or 2 to 6, wherein the one or more surfactant adsorber(s):(A) is a carbonaceous material, for example, the carbonaceous material comprises activated charcoal and optionally wherein the carbonaceous material is packed in a column, a cartridge, a sheet, a capsule, a pod or a bead and / or is impregnated into a porous material; or(B) comprises spherical silica beads filled with a three-dimensional hydrophobic polymer or rigid, cross-linked, spherical agarose.

8. The method of claim 7A, wherein the carbonaceous material is an activated carbon depth filter.

9. The method of any one of claims 2 to 8, wherein contacting the viral inactivated plasma sample or plasma fraction thereof to one or more surfactant adsorber(s) depletes the concentration of surfactant in the filtrate to:(i) below the limit of detection, for example, the concentration of surfactant in the filtrate is less than 50 ppm, or less than 20 ppm, or less than 10 ppm, or less than 5ppm, or less than 0.5ppm;(ii) below the critical micelle concentration of the surfactant, for example, the critical micelle concentration of the surfactant is less than 0.05%wt, or less than 0.01%wt, or less than 0.007%wt, or less than 0.005%wt, or less than 0.004%wt.

10. The method of any one of claims IB or 2 to 9, wherein the surfactant adsorber removes at least 95%, or at least 98%, or at least 99% of the surfactant from the viral inactivated plasma sample or plasma fraction thereof.

11. The method of any one of claims IB or 2 to 10, wherein the method comprises: (i) contacting the viral inactivated plasma sample or plasma fraction thereof to one surfactant adsorber after the viral inactivation step and collecting a filtrate from the surfactant adsorber wherein the filtrate comprises the viral inactivated plasma protein preparation; or(ii) contacting the viral inactivated plasma sample or plasma fraction thereof to a first and a second surfactant adsorber after the viral inactivation step, optionally wherein the method comprises contacting the first surfactant adsorber with the viral inactivated plasma sample or plasma fraction thereof at a concentration above the surfactant adsorber’s dynamic binding capacity for the surfactant.

12. The method of any one of claims IB or 2 to 11, wherein:(A)(i) the surfactant adsorber has a dynamic binding capacity of at least 200 g of surfactant / m2of adsorber, or at least 250 g of surfactant / m2of adsorber; and / or (ii) the one or more surfactant adsorber(s) have a total surfactant binding capacity of at least 250 g surfactant / m2of adsorber, or at least 300 g surfactant / m2of adsorber, or at least 350 g surfactant / m2of adsorber; and / or(iii) the one or more surfactant adsorber(s) have a total surface area (m2) to plasma volume (L) ratio of between 1:500 and 1:600; or(B)(i) the surfactant adsorber has a dynamic binding capacity of at least 100 g of surfactant / L of adsorber, or at least 120 g of surfactant / L of adsorber; or(ii) the one or more surfactant adsorber(s) have a total surfactant binding capacity of at least 100 g surfactant / L of adsorber, or at least 120 g surfactant / m2of adsorber, or at least 150 g surfactant / m2of adsorber; and / or(iii) the one or more surfactant adsorber(s) have a total surface area (m2) to plasma volume (L) ratio of between 1:500 and 1:600.

13. The method of any one of claims 11 (ii) or 12, wherein the method further comprises collecting a filtrate from the second surfactant adsorber wherein the second filtrate comprises the viral inactivated plasma protein preparation.

14. The method of any one of claims IB or 2 to 13, wherein the method further comprises washing the one or more surfactant adsorbers with one or more post-load wash buffers selected from the group consisting of a phosphate buffer, a sodium citrate buffer, a 2-(N-morpholino)ethanesulfonic acid buffer, an acetic acid buffer, a Bis-tris buffer and a L-histidine buffer, optionally wherein the post-load wash buffer comprises a phosphate buffer at a pH in the range of 4.0 to 6.0.

15. The method of any one of claims IB or 2 to 14, wherein the method further comprises contacting the viral inactivated plasma protein preparation to a chromatography medium after the one or more surfactant adsorber(s) to produce a purified plasma protein preparation, optionally wherein the chromatography medium is an anion exchange chromatography medium, for example, the anion exchange chromatography step comprises using a strong anion exchange resin operated in flow through mode, and optionally wherein the strong anion exchange resin comprises a matrix consisting of a poly(styrene-divinylbenzene) matrix, for example, a quatemized polyethyleneimine functional group or a quaternary amine functional group.

16. The method of claim 15, wherein the anion exchange chromatography step comprises a post-load wash buffer selected from the group consisting of a phosphate buffer, a sodium citrate buffer, a 2-(N-morpholino)ethanesulfonic acid buffer, an acetic acid buffer, a Bis-tris buffer and a L-histidine buffer, optionally wherein the post-load wash buffer comprises a phosphate buffer at a pH in the range of 5.8 to 6.6 and optionally wherein the post-load wash buffer further comprises sodium chloride at a concentration of between 0 mM and 50 mM.

17. The method of any one of claims 1A or 15 or 16, wherein the method further comprises adjusting the pH of the viral inactivated plasma protein preparation prior to loading onto the chromatography medium, for example, the pH of the viral inactivated plasma protein preparation is adjusted to a pH of between 6.0 and 7.0, optionally whereinthe pH of the viral inactivated plasma protein preparation is adjusted to a pH of 6.5 with IM Tris(hydroxymethyl)aminomethane.

18. The method of any one of claims 1 to 17, wherein at least 75% of the plasma protein from the plasma sample or fraction thereof is recovered in the purified plasma protein preparation and optionally wherein the plasma protein in the purified plasma protein preparation has a purity of at least 95% or at least 98%.

19. The method of any one of claims 1 to 18, wherein the plasma protein is selected from the group consisting of immunoglobulin G (IgG), a RhD immunoglobulin protein product, an apolipoprotein Al, an albumin, a protease, plasminogen, an alpha- 1-antitrypsin, a fibrinogen, a von Willebrand factor, an activated clotting factor, a prekallikrein activator (PKA), a prothrombin complex, a Cl esterase inhibitor, a protein C, an anti-thrombin III, alpha acid glycoprotein, haptoglobin, hemopexin, transferrin, Factor H, a coagulation factor, an oligomeric form or degradation product of any of the foregoing and combinations thereof.

20. The method of any one of claims 1 to 19, wherein the level of one or more impurities in the purified plasma preparation is reduced compared to the plasma sample or fraction thereof, for example, wherein the one or more impurities is selected from the group consisting of an IgA, an IgM, a RhD immunoglobulin protein product, an apolipoprotein Al, an albumin, a protease, plasminogen, an alpha- 1- antitrypsin, a fibrinogen, a von Willebrand factor, an activated clotting factor, a prekallikrein activator (PKA), a prothrombin complex, a Cl esterase inhibitor, a protein C, an anti-thrombin III, alpha acid glycoprotein, haptoglobin, hemopexin, transferrin, Factor H, a coagulation factor, a virus, an endotoxin, an oligomeric form or degradation product of any of the foregoing and combinations thereof,wherein:(i) the virus is selected from the group consisting of vaccinia virus (VV), human immunodeficiency virus (HIV), pseudorabies virus (PRV), bovine viral diarrhea virus (BVDV), West Nile virus (WNV), encephalomyocarditis virus (EMCV), minute virus of mice (MVM), parvovirus B19 (B19V), Xenotropic Murine Leukemia Virus (XMuLV), vesticular stomatitis virus (VSV) and combinations thereof;(ii)the coagulation factor is factor Xa, factor VII, factor VIII, a factor IX, factor XII, factor XIII and / or factor XI; and / or(iii)the protease is a serine protease or a plasmin.

21. The method of claims 19 or 20, wherein the purified plasma protein preparation comprises:(i) less than 20 pg, or less than 15 pg of immunoglobulin M (IgM) per g of IgG in the purified plasma preparation; and / or(ii) less than 30 pg, or less than 25 pg of albumin per g of IgG in the purified plasma protein preparation; and / or(iii) less than 3.0%, or less than 2.0%, or less than 0.1% aggregates; and / or(iv) less than 10 milli-units (mU), or less than 5 mU, or less than 1 mU of Factor XI / mL of the purified plasma protein preparation; and / or(v) less than 200 International -units (IU), or less than 150 IU, or less than 100 IU, or less than 80 IU of anti-Streptolysin 0 / mL of the purified plasma protein preparation.

22. The method of any one of claims 1 to 21, wherein the plasma sample or fraction thereof is selected the group consisting of a blood-derived plasma sample, an IgG intermediate fraction, a cryo-rich plasma, a cryo-poor plasma, a Supernatant I (SN I), a Cohn Fraction II (Fr II), a Cohn Fraction II+III (Fr II+III), a Cohn Fraction 1+11+111 (FrI+II+III), a Kistler / Nitschmann Precipitate A (KN A), a Kistler / Nitschmann Precipitate B (KN B), a Kistler / Nitschmann Precipitate of Supernatant B (KN B+l), an IgG depleted intermediate fraction and combinations thereof.

23. The method of any one of claims 1 to 22, wherein the method further comprises one or more steps selected from a group consisting of ethanol precipitation, octanoic acid fractionation, affinity chromatography, viral filtration, ultrafiltration / diafiltration and combinations thereof.

24. The method of any one of claims 1 to 23, wherein the method is performed at large scale, for example, the method is performed using at least 500kg, or at least 1000kg, or at least 2500kg, or at least 5000kg, or at least 7500kg, or at least 10000kg, or at least 12500kg, or at least 15000kg of the plasma or fraction thereof.

25. A composition comprising a purified plasma protein preparation produced by or obtainable by a method of any one of claims 1 to 24.

26. A composition comprising an immunoglobulin G (IgG), wherein the composition comprises Myristyldimethylamine-N-oxide (TDAO) and wherein:(i) the concentration of TDAO is less than 20 ppm, or less than 10 ppm, or less than 5ppm of TDAO, or less than 0.5ppm of TDAO;(ii) the concentration of TDAO is less than the critical micelle concentration of TDAO;and / or(iii) the concentration of TDAO is less than 0.05%wt, or less than 0.01%wt, or less than 0.007%wt, or less than 0.005%wt, or less than 0.004%wt;(iv) the Logio titre of one or more viruses selected from vaccinia virus (VV), human immunodeficiency virus (HIV), pseudorabies virus (PRV), bovine viral diarrhea virus (BVDV), West Nile virus (WNV), encephalomyocarditis virus (EMCV), minute virus of mice (MVM), parvovirus B19 (B19V) and combinations thereof is less than 2.0.

27. The composition of claims 25 or 26, wherein the IgG is an affinity purified IgG.

28. The composition of any one of claims 25 to 27, wherein the composition comprises:(i) 100 mg / mL of total human plasma protein and / or 20 g / 100 mL of total human plasma protein;(ii) a purity of at least 98% immunoglobulin G (IgG);(iii) a nominal osmolality of 320 mOsm / kg;(iv) a pH of between 4.6 and 5.0, or a pH of 4.8;(v) 250 mmol / L of L-proline;(vi) a sodium content of <1 mmol / L;(vii) an IgA content of < 0.05 mg / mL; and / or(viii) a Prekallikrein activator (PKA) level of < 35 lU / mL.

29. The composition of any one of claims 25 to 28, for use in treating, preventing and / or delaying progression of a condition in a subject.

30. The composition for use of claim 29, wherein the condition is selected from a group consisting of primary immunodeficiency disease (PI), chronic inflammatory demyelinating polyneuropathy (CIDP), and chronic immune thrombocytopenic purpura (ITP).

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