527 results about "Virus inactivation" patented technology

The invention relates to a viral-safe platelet extract, to its preparation and use. The extract comprises a mixture of biologically active platelet derived factors.

Advantageously, the extract comprises a balanced proportion of the factors and is non-clottable.

The invention discloses a coronavirus rapid detection kit based on S protein ligand and ACE2 receptor competitive chromatography. The coronavirus rapid detection kit comprises quantum dot labeled ACE2protein, quantum dot labeled rabbit IgG, recombinant coronavirus spinous process protein S1, goat anti-rabbit IgG polyclonal antibody, an immunochromatographic test strip and other materials. The detection sensitivity is improved through quantum dot fluorescence labeling and multistage coupling amplification signals, the detection specificity is improved and the antibody research and developmentcycle is avoided by utilizing the ligand and receptor binding principle, the kit capable of rapidly detecting coronavirus is provided, and the biosafety in the detection process is guaranteed by establishing a virus inactivation system. The kit disclosed by the invention is suitable for detecting various biological samples and environmental samples such as oral mucosa liquid, respiratory tracts, whole blood, plasma, serum, excrement and the like, and can be applied to rapid detection of coronaviruses taking ACE2 as a receptor, such as SARS-CoV-19, SARS-CoV, HCoV-NL63 and the like.

The invention discloses a novel coronavirus pneumonia (COVID-19) serological diagnosis kit. The kit comprises an S-IgM/IgG test strip and an N-IgM/IgG test strip, the double-antigen quadruple detection kit can be used for simultaneously detecting four indexes of an IgM/IgG antibody for resisting novel coronavirus spinous process protein S and an IgM/IgG antibody for resisting novel coronavirus nucleocapsid protein N in serum of a patient suffering from novel coronavirus pneumonia COVID-19. According to the kit, the detection sensitivity is improved through quantum dot fluorescence labeling andmultistage coupling amplification signals, the detection accuracy is improved through double-antigen quadruple detection, and the biological safety in the detection process is guaranteed by establishing a virus inactivation system. The kit is suitable for whole blood, plasma and serum detection, and can be applied to novel COVID-19 serological diagnosis.

The invention belongs to the biochemistry technical field, concretely relates to a method for purifying anti-HER2 or/and anti-HER3 antibody proteins. The method of the invention comprises the following the steps: clarifying a broth, carrying out affinity chromatography, carrying out inactivation on virus by acidic pH value, carrying out cation exchange chromatography, carrying out anion exchange chromatography; and filtering virus; wherein, the step of virus inactivation by acidic pH value and the step of virus filtration can be inserted at any position of the step after the affinity chromatography. The method of the invention comprises the following advantages that: 1) the chromatography step can be reduced to three steps, thereby the production efficiency can be enhanced and the production cost can be minimized. 2) the step of virus filtration is added, thereby the security can be raised.

The invention relates to a method for separating and purifying human immunoglobulin from a component I+III of blood plasma, and aims to provide a high-efficiency method for recovering high-purity human immunoglobulin. According to the technical scheme provided by the invention, the method comprises the following steps of: a, fully dissolving component I+III precipitate; b, precipitating with octylic acid and removing lipid and a part of impurity protein to prepare IgG (Immunoglobulin G); c, purifying through anion exchange column chromatography; and d, collecting flow-through liquid, performing membrane nanofiltration, ultrafiltration and concentration, preparing the human immunoglobulin, sterilizing and packaging. The method has the beneficial effects of capability of being operated at the room temperature, simple and short steps, high yield, low energy consumption and high output and is suitable for mass production; comprehensive utilization of the blood plasma is fully realized; the time of the entire production process is shortened; the cost is reduced; extremely considerable economic benefit can be produced; the safety of a product is guaranteed by using two virus inactivation/elimination methods of different mechanisms; the environmental pollution is avoided; and the method has high economic and social values.

The invention provides a composition of instant freeze-dried fibrinogen and thrombin preparation, a preparation method and a use thereof, and the composition comprises composition 1 composed of 35-70mg/ml of fibrinogen, 9-15mg/ml of sodium citrate, 7-12mg/ml of sodium chloride, 0.3-0.6mg/ml of polysorbate-80, 10-15mg/ml of mannitol, 4 -8mg/ml of arginine and 3.5-5.5mg/ml of glutamic acid by mg/ml and composition 2 composed of 700-1,200 mg/ml of thrombin, 3-6mg/ml of dextran 20, 15-25mg/ml of glycine, 5-7mg/ml of sodium chloride and 4-7mg/ml of calcium chloride by mg/ml. A sealant avoids the risk of spreading of AIDS virus, and the like, increases the drug stability, reduces the degeneration during the virus inactivation process by dry-heat method, protects biological activity, avoids local liquid storage of the using part caused by high permeability and the irritation of a large amount of inorganic salts to tissues, is conductive to the healing of trauma sites and ensures product safety and independent package to the maximum extent, thereby increasing storage time, facilitating use and meeting the clinical and field first-aid needs.

The invention provides a preparation method for fibrinogen with the advantages of high dissolution rate in the production process, short production period, fast solubility in clinical use, good biological activity, high safety in clinical use and high yield. An aid is added into supernate anticoagulant plasma. Compared with the prior art, the preparation method has the advantages that: 1, the preparation method provided by the invention is high in extraction efficiency; 2, the aid adopted in the method can improve the quality of the fibrinogen product, and plays a role in protecting the biological activities of the fibrinogen and blood coagulation factors XIII in virus inactivation and cold ethanol settlement processes; 3, in the process, the process solubility time of the fibrinogen is shortened to about 10 minutes; and 4, the solubility time of the freeze dried product of the fibrinogen is within 30 seconds, so precious time is won for rescuing patients in time in clinic.

The invention relates to a method for effectively removing a host protein in a monoclonal antibody downstream purification process. The method comprises the following steps: (1) performing deep filtration on cell culture fluid, and collecting the filtrate; (2) performing Protein A affinity chromatography on the filtrate obtained in the step (1); (3) performing virus inactivation on the sample obtained in the step (2), performing deep filtering on the sample subjected to virus inactivation, thereby effectively removing the host protein in the sample containing the monoclonal antibody. According to the method disclosed by the invention, the deep filtering after virus inactivation is adopted, the deep filtering process after Protein A affinity chromatography and virus inactivation is optimized, the content of HCP in the culture fluid supernatant collected by deep filtering can be reduced to 2.3ppm by virtue of two purification steps, namely the Protein A affinity chromatography and deep filtering after virus inactivation, and the content of the HCP can be reduced to 0.4ppm by virtue of further anion and cation exchange chromatography.

The invention provides a technology for extracting human blood coagulation factor VIII and human fibrinogen from plasma constituent precipitation. The preparation technology comprises the following steps: fresh plasma is subjected to primary sedimentation, so that blood coagulation factor VIII and fibrinogen precipitation can be jointly precipitated from the plasma; the primary precipitation is subjected to suspension; the suspension liquid is subjected to centrifugal separation to obtain supernatant; the centrifugally separated supernatant is subjected to virus inactivation and chromatography refining to respectively obtain human blood coagulation factor VIII refined liquid used for preparing human blood coagulation factor VIII products and chromatography effluent used for preparing human fibrinogen products. According to the invention, the human blood coagulation factor VIII and the human fibrinogen are precipitated through the one-step plasma constituent precipitation, and an ion-exchange column chromatography technology is adopted to perform purification preparation of the human blood coagulation factor VIII and the human fibrinogen, so that the deficiency that the human fibrinogen cannot be normally produced as the human blood coagulation factor VIII is prepared through cryoprecipitation is overcome.

A yolk antibody for SARS coronavirus is prepared through injecting the antigen, which may be recombinant genetic protein S, M, or E,or the antigen epitope for said protein able to represent SARS coronavirus, or the synthetic polypeptide of said protein, etc, in health hen for primary immunizing, booster immunizing, collecting its egg, extracting yolk, and extracting the yolk antibody from it. It can also be prepared to become liquid preparation. It can be used to prevent SARS.

The invention relates to a biological amnion and a preparation method thereof. The biological amnion has three layers including a slow release layer, an amnion layer and a collagen layer from top to bottom, wherein the slow release layer consists of collagen and biological active factors, the amnion layer consists of an amnion subjected to decellularization treatment, and the collagen layer is formed by freeze-drying and compounding collagen. The biological amnion is prepared through the steps of raw material pretreatment, virus inactivation, decellularization treatm. The biological amnion prepared by the invention has the characteristics of an effect of slowly releasing the active factors, low antigenicity on removing epithelial cells, convenience in product operation, difficulty in curling, good adhesiveness with surrounding tissues, difficulty in sliding and the like. Meanwhile, by using a process for performing the decellularization treatment on the amnion, disclosed by the invention, a natural compact collagen structure in the amnion can be effectively retained, the biological amnion can fully achieve a physical barrier effect after being applied to tenorrhaphy, and an animal experiment proves that the biological amnion can effectively achieve an effect of preventing tissue adhesion.

The invention relates to a preparation process of a human prothrombin compound, belonging to the field of biological pharmacy. The preparation process comprises the following steps of: absorbing blood plasma, washing, eluting and clarifying by filtration; inactivating viruses by using the S/D (Solvent/Detergent) method; purifying by absorption; subpackaging; freeze-drying; and inactivating viruses by the dry heat method. The human prothrombin compound is directly absorbed from blood plasma by using gel, only the gel chromatography technology is used in the entire extraction process, so that the production steps are simplified, the pollution of various factors on the production process of the product is reduced, meanwhile, the yield of the product is increased by 25-30%. In addition, the S/D method is used for removing lipid-enveloped viruses and the dry heat method is used for removing non lipid-enveloped viruses in the production process, and the safety of clinic medication is obviously increased through the two virus inactivation steps.

The present invention provides: an antibacterial/antiviral composition which has excellent antibacterial/antiviral activity under visible light irradiation; an antibacterial/antiviral agent; a photocatalyst; and a bacteriairus inactivation method. An antibacterial/antiviral composition according to the present invention contains titanium oxide on which both a divalent copper compound and a silver compound are loaded. An antibacterial/antiviral agent according to the present invention and a photocatalyst according to the present invention contain an antibacterial/antiviral composition according to the present invention. A bacteriairus inactivation method according to the present invention inactivates bacteria and a virus with use of an antibacterial/antiviral composition according to the present invention, an antibacterial/antiviral agent according to the present invention or a photocatalyst according to the present invention.

The invention provides a method for preparing human immunoglobulin. The method comprises the following steps of: dissolving Cohn components I, II and III and Cohn components II and III, precipitating by using octanoic acid, performing anion-exchange chromatography for the first time, precipitating IgM, performing anion-exchange chromatography for the second time, performing ultrafiltration or dialyzing, preparing, inactivating virus and the like to obtain the high-purity human immunoglobulin. The invention also provides the human immunoglobulin prepared by the method and a medicinal composition. The method for preparing the human immunoglobulin is simple, and low in cost and has good industrial application prospect.

The invention relates to a method for producing a human prothrombin complex. The method is characterized in that the following steps of direct separation and extraction from blood plasma, virus inactivation, refining and secondary virus inactivation are adopted to obtain finished human prothrombin complex. As the method adopts the step of direct separation and extraction from the blood plasma, the separation condition is mild, the batch-to-batch difference of the products is small, the blood coagulation factor activity is stable, the yield rate is high, and the activation phenomenon basicallydoes not exist. The virus inactivation process adopts a method of combining an S/D (organic solvent/detergent) method and a dry and thermal activation method and fully ensures that the virus safety of the human prothrombin complex.

The invention provides a biological repair tablet for herniae and a preparation method thereof. The repair tablet uses small intestine submucosa tissues of inbred line animals without cell and DNA (deoxyribonucleic acid) components as the raw material, completely reserves the extracellular matrix component and structure, and has a micropore structure. The preparation method of the repair tablet comprises the following operation steps: determination of animal source, pretreatment and rough cleaning of small intestine tissues, virus inactivation, cell removal, DNA removal treatment, formation, packaging and sterilization. The biological repair tablet for herniae prepared by the method uses an inbred line animal as an animal source, and thus, the hereditary features are pure, stable and uniform, thereby radically ensuring the stability and uniformity of different batches of products; and the biological repair tablet for herniae has fewer animal source DNA residues, completely reserves the three-dimensional structure of natural ECM, and has the advantages of low immune source property and high infection resistance.

The invention discloses a compound growth factor of blood platelet sources as well as a preparation method and application of the compound growth factor. According to the compound growth factor as well as the preparation method and the application of the compound growth factor, platelet-rich plasma as the raw material is firstly subjected to virus inactivation through an S/D (Solvent/Detergent) method to remove such reagents as organic solvents and eradicators in the platelet-rich plasma and then activated by adding calcium or/and thrombin, supernatant fluid after activation is extracted to obtain the compound growth factor fitting for the natural proportion of the human body; and the problems that single recombinant growth factors in clinic are high in price, and difficult to purify, is involved into gene recombination biological safety and on the like are overcome. The invention further discloses a compound growth factor gel obtained based on the compound growth factor by adding chitosan microspheres carriers, which can slowly release growth factors during use. The compound growth factor has remarkable treatment effects for acute wounds, burns, cosmetic treatment, and chronic hard-healing wounds, is convenient to use, and has high safety.

The invention relates to the technical field of biological product and blood product production, and mainly relates to a separation and purification method of human serum albumin in the blood product production, in particular to a preparing method of human serum albumin. According to the method, healthy plasma supernatant is used as raw materials; a Kistler-Nitchmann low-temperature ethanol method is adopted for precipitating and separating ingredients FI+II+III and ingredients FIV; supernatant after the ingredient FIV separation is subjected to dealcoholization treatment; then, one-step ion exchange chromatography and ultrafiltration are further performed; a proper amount of sodium caprylate is added as a stabilizer; after the Pasteur virus inactivation treatment is performed, the human serum albumin finished product is obtained. Through efficient liquid chromatography detection, the purity of the human serum albumin prepared by the process is higher than 99 percent; the polymer content is lower than or equal to 1 percent; the yield of the plasma reaches 28 to 30g/L. The purity of the product is higher; the impurity protein content is lower, so that the clinical medication is safer.

The invention belongs to the field of blood products in biological products, in particular relates to a method for extracting human TIG (Tetanus Immune Globulin) based on chromatography. The method comprises the following three steps: 1, primary separation; 2, purification by chromatography; and 3, virus inactivation. When the chromatography process provided by the invention is used for further purifying products, the purity of the products is improved greatly, the purity of human TIC in the products can be improved to above 98%, which is not only far higher than the standard specified in Chinese Pharmacopoeia version 2010, but also higher than the standard specified in European Pharmacopoeia; in addition, the contents of other impurities causing anaphylactic reaction are reduced greatly, for instance, two major anaphylactic substances, namely anticomplement active substance (ACA) and depressor substance (PKA), are both reduced remarkably. Two different virus inactivation processes, namely low-pH incubation and nano-film filtering, are adopted in the invention and can be used for effectively inactivating and removing both lipid-enveloped viruses and non lipid-enveloped viruses.

The invention discloses a coxsackievirus A6 type infected animal model as well as a preparation method and an application thereof. The preparation method of the coxsackievirus A6 type infected animal model provided by the invention comprises a step of infecting an animal with an inactivated coxsackievirus A6 type strain, so that the coxsackievirus A6 type infected animal model is obtained, wherein the coxsackievirus A6 type strain is preserved in China General Microbiological Culture Collection Center with preservation number of CGMCC No.13393. The coxsackievirus A6 type infected animal model, which is stable and is good in repeatability, is constructed on the basis of the CVA6 strain WF057R; and with the application of the model, a research tool is provided for next medicine antiviral therapy and assessment of an immune protective effect of an inactivated viral vaccine.

The invention relates to a preparing method of a heterogeneous acellular dermal matrix substrate with good biocompatibility. The method concretely comprises the following steps of (1) split thickness skin graft preparation; (2) epidermis and dermis separation; (3) acellular processing; (4) cross linking; (5) virus inactivation; (6) refining; (7) Co-60 irradiation sterilization. The ecellular tissue engineering materials obtained by the method provided by the invention has the advantages that the toxicity is stable, and the cell compatibility is better.

The present invention relates to a separation, purification and virus inactivation process of high-purity haematoglobin which can be used as substitute for red blood cell. Said process is characterized by including the following steps: under the condition of 0-4deg.C using natural red blood cell and making it undergo the process of haematolysis treatment to obtain primary haemolytic solution, adding proper quantity of antioxidant to regulate pH value of solution, making physical deoxidation and chemical deoxidation to fully remove oxygen existed in the haematoglobin, then adding excess antioxidant and adding saccharide compound as protecting agent, heating for 10-12hr at 60-80deg.C and continuously introducing inert gas, then making conventional filtration and ultrafiltration membrane treatment and regulating pH to 7.0-7.4.