75 results about "Human immunoglobulin" patented technology

The invention relates to a preparation method and application of a human immune globulin preparation stock solution, the preparation method comprises the steps of pretreatment of an initial raw material, ultrafiltration concentration and dialysis, and virus inactivation and filtration, the ultrafiltration concentration and dialysis process is completed under the participation of a dialysis buffer solution composed of a main functional component L-proline, and the human immune globulin preparation stock solution is obtained. The L-proline is used for effectively protecting human immune globulin in the preparation process of the human immune globulin preparation stock solution and the preparation, so that the influence of various unstable factors possibly causing polymerization of the human immune globulin product in the preparation process of the human immune globulin product in the prior art is effectively overcome; therefore, the stability and the quality of the human immune globulin preparation stock solution and the prepared product are effectively improved, and compared with the prior art, the technical scheme provided by the invention is simple, convenient and practical, and can achieve an extremely good technical effect, so that the human immune globulin preparation has outstanding beneficial effects and remarkable progress, and has extremely high popularization and application values.

The invention discloses a method for detecting the biological activity of human immunoglobulin ADCP, which is characterized in that CHO-K1 / SPIKESARS2 is taken as a target cell, THP-1 cells (human leukemia monocytes which naturally express CD32a (Fc gamma RIIa) and CD64a (Fc gamma RIIa) and stably transfect NF-kB-Luc luciferase reporter genes) modified by genetic engineering are taken as effector cells, and a fluorescence reporter gene method is adopted for detection. Based on specific target cells and effector cells, the ADCP biological activity of two different human immune globulin preparations, namely intravenous injection human immune globulin and subcutaneous injection human immune globulin, can be accurately and reliably reflected by a drawn dose-effect curve through a detection system matched with specific human immune globulin solution concentration, and the method is simple and easy to implement. Cost is low, and practical application and popularization value is achieved.

The present invention relates to stable formulations of antibodies or antigen-binding fragments thereof that bind to human immunoglobulin-like transcript 4 (ILT4). The formulations provided herein may also include buffers, non-ionic surfactants, non-reducing sugars, antioxidants, and other compositions and adjuvants. Also provided are methods of treating various cancers using the formulations disclosed herein. The formulations can be prepared as a medicament and administered to a patient in need thereof.

The invention relates to a pair of anti-TSH receptor (TSHR) autoantibody-binding fusion proteins consisting of a capture fusion protein and a detection fusion protein, and a method for detecting autoantibodies to the thyroid stimulating hormone receptor (TSHR) in a biological fluid sample, which employs said fusion proteins pair. More specifically, the capture and detection fusion proteins of the pair of the invention comprise an extracellular domain of a human TSHR and a monomeric non-human immunoglobulin Fc domain, or fragment thereof, or a bacterial maltose binding protein (MBP). Also disclosed is a kit for carrying out the method of the invention. In a preferred embodiment, the method of the invention is a sandwich immunoassay.

To provide a humanized rodent that expresses a heavy chain containing a VL domain. [Solution] A non-human animal, tissue, cell, and genetic material is provided which includes a modification of an endogenous non-human heavy chain immunoglobulin sequence and contains functional ADAM6 activity in a rodent (e.g., mouse), wherein the non-human animal rearranges the human immunoglobulin light chain gene segment in relation to the heavy chain constant domain and expresses an immunoglobulin-like molecule which contains a human immunoglobulin light chain variable domain fused to the heavy chain constant domain and is a cognitive of a human immunoglobulin light chain variable domain fused to the light chain constant domain.

The invention relates to an anti-ovarian antibody chemiluminiscence kit and a preparation method thereof. The kit comprises amino magnetic beads coated with anti-ovarian antibody recombinant protein, anti-human immune globulin labeled by alkaline phosphatase, an anti-ovarian antibody calibrator and a chemiluminiscence substrate. The method has the beneficial effects that the 7-day acceleration stability of the AOAb coated amino magnetic bead is improved to 95% or above, the signal-to-noise ratio is high, the correlation coefficient is greater than 0.999, the test repeatability CV is less than 3.5%, the reagent correlation and the magnetic bead stability can be better improved, and the test result is ensured to be accurate. By optimizing the amino magnetic bead cross-linking agent, 60 clinical samples are tested and compared with the result of a comparison manufacturer, the total coincidence rate is as high as 98%, and false positive can be effectively reduced. Meanwhile, a detection system is formed by matching with a Guilin superior chemiluminescence immunoassay analyzer IA-260, the testing amount per hour reaches 130 tests, and compared with a traditional colloidal gold immunochromatography method and a traditional enzyme-linked immunosorbent assay method, the detection speed is greatly increased, and the result optimization accuracy is greatly improved.

The application discloses a nanobody 3A2 for human adenovirus and a preparation method and application thereof, and belongs to the technical field of biotechnology, and particularly relates to a nanobody 3A2 for human adenovirus and a preparation method and application thereof. The nanobody or antigen-binding fragment containing the nanobody for targeting human adenovirus has three complementarity determining regions CDR1, CDR2 and CDR3; the amino acid sequence of CDR1 is SEQ ID No. 1, the amino acid sequence of CDR2 is SEQ ID No. 2, and the amino acid sequence of CDR3 is SEQ ID No. 3. The nanobody 3A2 is fused with an Fc segment (hFc) of human immunoglobulin to obtain a fusion protein, and the obtained h3A2-hFc can effectively inhibit infection of human adenovirus type 55, and the IC 50 is 0.62 nM.

Provided are human anti-thymocyte globulin (ATG) products, and methods of making and using the same. In particular, the disclosure provides an ungulate-derived polyclonal immunoglobulin, comprising a population of fully human or substantially human immunoglobulins. The population of fully human or substantially human immunoglobulins specifically binds human thymocytes, T cells, B cells, and / or monocytes. Such compositions may be made by immunization of transgenic animals having a human Ig locus with human thymocytes. This method generates polyclonal immunoglobulin with yield, purity, and antigen specificity that enable the use of this product in medical applications.

The application discloses a fusion protein ABD / Fc / IL-2, a coding gene thereof, a preparation method and application, and belongs to the field of biopharmaceuticals. The fusion protein ABD / Fc / IL-2 provided comprises a human serum albumin binding domain ABD, a full-length human immunoglobulin Fc segment and IL-2 or a mutant thereof. The fusion protein can effectively stimulate the proliferation of immune cells in the body, enhance the immunity of the body, and has high biological activity and a long plasma circulation half-life, or has high biological activity, a long plasma circulation half-life and low toxic side effects. The fusion protein can be used for preparing medicines for treating various diseases such as malignant tumors, infectious diseases and low immunity of the body, and can play an important role in the fields of medicine and biopharmaceuticals.

The plasma mixing device for tetanus human immune globulin comprises a bottom plate, a sliding table is slidably connected to the top of the bottom plate, a driving assembly is arranged in the sliding table, a supporting rod is arranged at the top of the driving assembly and rotatably connected with the sliding table, a guiding assembly is arranged at the top of the supporting rod, and the guiding assembly is rotatably connected with the sliding table. A transmission rod is arranged at the top of the guide assembly, a supporting table is rotationally connected to the outer side of the transmission rod, the bottom of the supporting table is fixedly connected with the top of the sliding table, a cylinder is fixedly connected to the top of the transmission rod, a screw cap is in threaded connection with the top of the cylinder, and a disc is arranged on the rear side of the driving assembly. A cylindrical rod is arranged on the rear side of the disc, a limiting frame is connected to the rear side of the cylindrical rod in a sliding mode, and the problems that a simple stirring or shaking mode is mostly adopted in an existing uniform mixing device and method, the efficiency of the mode is low, uneven distribution of components in plasma is easily caused, and the quality and the effect of a final product are affected are effectively solved.

The invention relates to the technical field of immune globulin preparation systems, in particular to a human immune globulin preparation system for subcutaneous injection, which comprises the following modules: a visualization module, an intelligent monitoring module, a power supply module, a central control management module and an execution module, the central control management module is in communication connection with the visualization module, the intelligent monitoring module and the execution module, and the intelligent monitoring module is in communication connection with the visualization module. According to the full-automatic intelligent production system, a large number of production tasks can be completed in a short time through the automation and intelligentization technology, compared with traditional production, the production efficiency can be improved by several times or even dozens of times, the labor cost is greatly reduced, and in the low-temperature production environment with the high cleanliness requirement, the production efficiency is greatly improved. The full-automatic intelligent production line can reduce manual operation and reduce operation and pollution risks.

The invention relates to the technical field of preparation and application of bioindustry peptides and immune globulins, in particular to a preparation method of human immune globulins stored at normal temperature. The preparation method comprises the following steps: treating an FI + II + III / FII + III precipitation dissolving solution by using fumed silica Aerosil380, and adsorbing and removing unstable substances such as lipoprotein and lipoid in the precipitation dissolving solution so as to reduce protein polymerization caused by the unstable substances in a long-term normal-temperature storage process, so that the long-term stability of the human immune globulin is improved; l-proline is added into the final formula of the product to reduce the polymerization and oxidation effects of protein in the storage process, trace Tween 80 is added into the final formula of the product to reduce the viscosity of the protein, and the operation conditions of adding the L-proline through ultrafiltration and concentration are further optimized to further prevent or reduce the polymerization of the protein so as to realize normal-temperature storage of the human immune globulin.

The present application relates to the technical field of biological medicine, and more particularly to a multifunctional antibody K1932 binding human CD19, CD3 and Fc gamma R, wherein the multifunctional antibody is composed of a bivalent Fab fragment specifically recognizing CD19 on the surface of B lymphocyte, a bivalent single-chain antibody recognizing CD3 molecule on the surface of T lymphocyte, and a human immunoglobulin Fc domain binding with Fc receptor, wherein the single-chain antibody recognizing CD3 molecule is connected with the C-terminal of Fab light chain through a connecting peptide Linker1, and the heavy chain and the light chain of the CD3 single-chain antibody are connected by a flexible Linker2; the biological macromolecule with the three functional domains is a highly directional immunotherapy drug, which is suitable for injection administration, can guide T cells to attack CD19-positive B lymphocytes, and the Fc domain is combined with Fc gamma R, so that the in-vivo half-life of the biological macromolecule is adjusted and the unnecessary influence on normal cells is reduced.

The invention provides a method for preparing human immunoglobulin for intravenous injection by a sodium caprylate precipitation process. Comprising the following steps: raw material plasma preparation, FI reaction, FI + II + III separation, FI + II + III filter pressing, FI + II + III precipitation and dissolution, sodium caprylate precipitation reaction, filter pressing filtration, ultrafiltration concentration, DEAE chromatography, TMAE chromatography, ultrafiltration dialysis, nanofiltration, low-pH incubation, ultrafiltration concentration (stock solution), semi-finished product solution preparation, degerming and split charging to obtain the human immunoglobulin finished product for intravenous injection. According to the process, plasma is adopted as an initial raw material, FI + II + III is prepared through an ethanol reaction, and albumin, IgA, IgM and other impure proteins are removed more thoroughly through a method of sodium caprylate precipitation primary purification and multi-step chromatography refining purification, so that the risk of hemolysis and adverse reaction after infusion is reduced. Meanwhile, saccharides are not added into the preparation as a stabilizer, and safer glycine is used as the stabilizer, so that the kidney load of a patient is reduced.

This invention relates to the field of irregular antibody detection technology, specifically to an automated washing microfluidic chip for irregular antibody detection. The chip includes a chip body, a membrane, and a detection component comprising a sample application chamber and a detection chamber arranged sequentially away from the center of rotation. The sample application chamber and the detection chamber are connected by a washing channel. The detection component is pre-filled with a washing solution that can fill the detection chamber and the washing channel under centrifugation. The washing solution contains anti-human immunoglobulin that reacts with erythrocyte antigen-antibody complexes. The specific gravity of the washing solution is configured to be greater than the specific gravity of the sample to be tested but less than the specific gravity of the erythrocyte antigen. This configuration solves the problems of cumbersome procedures, excessive time consumption, high operator dependence, and difficulty in standardization caused by multiple manual washing steps required in traditional test tube methods for detecting irregular antibodies. It effectively ensures detection sensitivity and accuracy and reduces the false negative rate.

The purpose of the present invention is to provide, as a platform technique that may serve as preparation for pandemics, a rapid antibody production technique in which a non-human animal having a human antibody gene is used. More specifically, the purpose of the present invention is to provide an immunization method with which it is possible to induce, in a short period of time, a high antigen-binding ability of an antibody or a high antibody titer of an antiserum, and a method for producing a human antibody / antiserum with which it is possible to rapidly produce a wide range of neutralizing antibodies.　(1) An immunization method for rapidly inducing a human monoclonal antibody having a high ability to bind to a desired antigen or a human polyclonal antibody having a high antibody titer, the method comprising a step for immunizing a non-human animal a plurality of times with a desired antigen or a nucleic acid encoding the antigen within 30 days from the first immunization, the non-human animal having a human antibody gene or locus, and the non-human animal being such that an endogenous gene or locus of the non-human animal corresponding to the human antibody gene or locus is disrupted or deleted, or mutated so as to result in a loss of expression or low expression. (2) A method for producing a human antibody against a desired antigen using a non-human animal, the method comprising: an immunization step for immunizing the non-human animal with the antigen or a nucleic acid encoding the antigen; a human immunoglobulin-positive B cell isolation step for isolating B cells that are human immunoglobulin-positive from a tissue of the immunized non-human animal; an antibody base sequence acquisition step for acquiring the base sequences of antibody light-chain mRNA-derived cDNA and antibody heavy-chain mRNA-derived cDNA prepared from the isolated B cells; and an antibody production step for producing an antibody on the basis of the acquired antibody base sequence, the non-h

The invention relates to the technical field of biological pharmacy, and discloses a tetanus human immune globulin preparation method, which comprises: S1, plasma pretreatment: taking anticoagulant plasma with a tetanus antibody titer of more than or equal to 10 IU / mL, and carrying out filtration treatment on the anticoagulant plasma; an improved self-adaptive algorithm is adopted to determine various parameters in the extraction process, S3, composite chromatographic purification, S4, collaborative virus inactivation, and S5, preparation preparation. According to the method, through linkage of an improved adaptive particle swarm-response surface coupling algorithm, first, 40 groups of initial sample sets are constructed by Latin hypercube sampling, a double-response surface model (R2gt; 0.95) is fitted by using a quadratic polynomial, and then a particle swarm depends on the model to predict fitness and dynamically adjust inertia weight balance optimization. By means of the linkage, the TT-IgG extraction rate is increased by 13-15%, the impurity protein removal rate is increased by 14-16%, RSD of three parallel experiments is smaller than or equal to 3%, and it is guaranteed that parameters are accurate and repeated.

The application discloses a nanobody 2C10 for human adenovirus and a preparation method and application thereof, and belongs to the technical field of biotechnology, and particularly relates to a nanobody 2C10 for human adenovirus and a preparation method and application thereof. The nanobody or antigen-binding fragment containing the nanobody for targeting human adenovirus has three complementarity determining regions CDR1, CDR2 and CDR3; the amino acid sequence of CDR1 is SEQ ID No. 1, the amino acid sequence of CDR2 is SEQ ID No. 2, and the amino acid sequence of CDR3 is SEQ ID No. 3. The nanobody 2C10 is fused with an Fc segment (hFc) of human immunoglobulin to obtain a fusion protein, and the obtained h2C10-hFc can effectively inhibit infection of human adenovirus type 55, and the IC 50 is 5.33 nM.

The invention provides a method for detecting ADCP activity of human immune globulin products in the field of infectious diseases, and belongs to the technical field of immunological detection. The invention provides an accurate and visual immunoglobulin product antibody-dependent cell-mediated phagocytosis biological activity detection method through the steps of target cell screening, efficiency-target ratio optimization, test sample concentration gradient optimization and the like. The accurate detection on the biological activity of the antibody-dependent cell-mediated phagocytosis of the human immunoglobulin product is realized. The detection method disclosed by the invention is intuitive and high in precision and accuracy, fills the blank of detection of the antibody-dependent cell-mediated phagocytosis of the human immunoglobulin products at present, and has important significance in improving the quality control and clinical application of the human immunoglobulin products.

The invention discloses a technology for removing viruses from tetanus human immune globulin through a nano film. The process comprises the following steps: pretreating a feed liquid, so that the protein concentration of the feed liquid is 50-60g / L, the pH is 3.8-4.4, and the feed liquid contains 90-110g / L maltose and 50-150mmol / L sodium chloride; then, the feed liquid is subjected to two-stage filtration through a 0.1-micron nylon pre-filtration membrane bag with negative charges and a 20-nm regenerated cellulose (RC) virus removal membrane bag in sequence. According to the process, through optimizing the physical and chemical state of the feed liquid and the synergistic effect of the feed liquid and the functionalized filter membrane, the protein aggregation is effectively inhibited, the membrane pollution is reduced, the virus removal effect is ensured not to be lower than 4log10, the protein load of the RC membrane is remarkably improved to be more than 200L / m, and the product purity is more than or equal to 98%. The invention solves the technical problems of low flux and easy blockage of high-concentration immune globulin in small-aperture virus removal filtration, and is suitable for efficient, safe and large-scale production of blood products.

The invention belongs to the technical field of medical biology, and particularly relates to an EBV (Epstein-Barr Virus) neutralizing antibody-specifically-immune plasma high-throughput screening method and application thereof. EB virus envelope glycoprotein gp350 is selected as a screening target antigen, EBV specific plasma containing a high-titer EBV neutralizing antibody is rapidly screened in a high-throughput mode and used for preparing EBV specific human immune globulin, the titer of the EBV neutralizing antibody is obviously higher than that of listed intravenous gamma-C products, and the content of the EBV neutralizing antibody is about 4-8 times that of the EBV neutralizing antibody with the same concentration. The method provided by the invention can realize large-scale collection of EBV specific plasma through rapid high-throughput screening, reduces the workload of plasma screening, is suitable for large-scale production of EBV specific human immune globulin, and has a good application prospect.

The invention provides a monoclonal antibody of immunoglobulin A. The monoclonal antibody is a monoclonal antibody of specific immunoglobulin A secreted by a mouse anti-human immunoglobulin A monoclonal antibody hybridoma cell line 5F5A4F3 strain, can be used for quantitatively detecting the concentration of RBD-IgA generated by stimulation of a specific antigen, and also can be used for quantitatively detecting the concentration of the immunoglobulin A. The immunoglobulin A monoclonal antibody can be used for detecting the immunoglobulin A monoclonal antibody, can also be used for quantitatively detecting the concentration of total IgA generated by mucosal immunity, and is good in linearity, high in sensitivity, strong in specificity, suitable for evaluating the immune effect of vaccines, and also suitable for screening and monitoring the IgA antibody level in large-scale people.

The invention belongs to the field of biological medicines and medicinal preparations, and relates to a kynurenase-Fc fusion protein, a nano medicinal preparation thereof, a preparation method and application. The kynureninase-Fc fusion protein is formed by connecting kynureninase (KYNase) and an Fc structural domain of human immune globulin G. The invention further discloses a preparation method of the kynureninase-Fc fusion protein. Compared with PEG modified kynureninase, the kynureninase-Fc fusion protein has the advantages that the half-life period of KYNase in whole blood can be remarkably prolonged while the original KYNase activity is maintained, the concentration of a medicine at a tumor site is increased, and the anti-tumor effect of KYNase is improved. The nano-drug preparation based on the kynureninase-Fc fusion protein is prepared from the kynureninase-Fc fusion protein and a photosensitizer. According to the nano-drug preparation, the drug photosensitizer is entrapped in a non-covalent bond combination manner, so that the enrichment of the photosensitizer at a tumor site is improved, and the half-life period of the photosensitizer in whole blood is not changed. The kynureninase-Fc fusion protein provided by the invention can be used for anti-tumor immunotherapy, and the immunotherapy effect of tumor photodynamic therapy combined with kynureninase is enhanced.

The utility model belongs to the technical field of separation and extraction equipment, and particularly relates to tetanus human immune globulin separation and extraction equipment which comprises a protective shell, a rotating disc is rotatably mounted in the protective shell, a plurality of placement cavities and a first power cavity are formed in the rotating disc, and clamping rods are slidably mounted in the first power cavity and located on the two sides of the placement cavities; one end of the clamping rod penetrates through the power cavity I and extends into the corresponding placing cavity; the driving assembly is located in the protective shell and used for driving the rotating disc to rotate and driving the multiple clamping rods to slide; the fixed block is fixedly mounted on one side of the protective shell, a sliding groove is formed in the fixed block, and a storage tank is slidably mounted in the sliding groove, so that the positions of the plurality of test tubes can be clamped and fixed, the stability of the test tubes during rotation is ensured, and meanwhile, to-be-extracted products in the plurality of test tubes are ensured to be the same; the same time and rotating speed required by separation and extraction of a plurality of test tubes are ensured, and the same quality of separated and extracted products is ensured.

This utility model relates to the technical field of human immunoglobulin preparation devices, and discloses a sampling device for preparing tetanus human immunoglobulin. It includes a sampling cylinder with a low-temperature storage mechanism on its outer wall and an automatic sampling mechanism. The low-temperature storage mechanism includes a first support ring, a supporting outer cylinder fixedly mounted at the bottom of the first support ring, and a second support ring fixedly mounted at the bottom of the supporting outer cylinder. Through the design of the low-temperature storage mechanism, this utility model can store a low-temperature medium in the cavity formed by the first support ring, the supporting outer cylinder, the second support ring, and the copper inner cylinder. The low-temperature medium can pass through the copper inner cylinder to cool the inner cavity of the sampling cylinder, thus achieving the function of low-temperature storage of the sample inside the sampling cylinder. This avoids the problem of sample deterioration during storage due to high ambient temperatures, ensuring the accuracy of biochemical analysis.

The present invention provides a recombinant fusion protein based on AK183 protease and its application in treating IgA nephropathy and other related diseases mediated by IgA complex deposition, wherein the recombinant fusion protein structure comprises a human commensal bacteria protease AK183 active region and a human immunoglobulin fragment; the human immunoglobulin fragment is located at the N-terminus of the protease AK183 active region. The present invention also provides a method for preparing the recombinant fusion protein. The recombinant fusion protein of the present invention has the comprehensive advantages of prolonged plasma half-life, effective clearance of circulating and renal IgA complexes, and greatly reducing the immunogenic side effects of the protease on the human body, by recombinantly fusing the natural AK183 protease with the human immunoglobulin fragment, and is suitable for specific treatment of IgA nephropathy and other related diseases mediated by IgA complex deposition.

The present invention provides antibodies and antigen-binding fragments thereof that specifically bind human immunoglobulin E (IgE) with greater affinity at neutral pH than at acidic pH.

The invention relates to the technical field of immunodetection, and discloses an immunochromatography reagent for detecting an antiproteinase 3 antibody and application, which are used for detecting the antiproteinase 3 antibody in human serum, plasma or whole blood and assisting in diagnosing wegener granuloma. The sample pad is used for bearing a to-be-detected sample; the combination pad is coated with an anti-human immune globulin antibody or an anti-human IgG antibody marked by a marker; the detection line is coated with a recombinant protease 3 antigen, myeloperoxidase antigen fragments related to Wegner granuloma attack are added, and hydrophilic polysaccharides are adopted as spacer arms to be arranged at intervals; the quality control line is coated with a goat anti-mouse IgG antibody; the water absorption pad is used for absorbing liquid in the chromatography process and promoting the liquid to flow unidirectionally; the bottom plate is used for bearing all the components, and all the components are sequentially and mutually assembled on the bottom plate to form a detection test strip; the immunochromatography reagent is extremely simple and convenient to operate, professional laboratory equipment and complex operation skills are not needed, and a detection result can be obtained only by dropwise adding a sample onto the test strip.

Genetically modified rodents whose immunoglobulin light chain loci are engineered to be inserted into human immunoglobulin light chain gene segments are disclosed, which rodents are capable of normal reproduction and producing human light chain containing antibodies. The invention also provides a method of making the genetically modified rodent and a use of the rodent.

The invention provides a detection method and a detection kit for biological activity of human immunoglobulin antibody-dependent cell-mediated phagocytosis, and belongs to the technical field of biological detection. According to the present invention, the hPBMC induced hMDMs is adopted as the effector cell, the Sp2 / 0-Ag14 cell expressing the alpha-Gal antigen is adopted as the target cell, and the accurate detection of the immunoglobulin product ADCP biological activity is achieved under the appropriate effect-target ratio and the test sample concentration gradient; the detection method disclosed by the invention is intuitive in operation and high in precision and accuracy, fills the blank of ADCP detection of the immunoglobulin product at present, and is of great significance for improving quality control and clinical application of the immunoglobulin product.