Preparation method of plasma human immunoglobulin

A human immunoglobulin and plasma technology, applied in the preparation methods of serum immunoglobulins, immunoglobulins, peptides, etc., can solve the problems of quality control of immunoglobulin finished products, and achieve the cost saving of gelation and the reduction of load. Effect

Active Publication Date: 2019-03-12
SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technology allows for direct extraction from blood samples containing fibrous proteins called heparan sulfate proteoglycans (HSPG). These HSPG bind strongly to certain types of metal ion chelators like EDTA which help them attach themselves to other molecules on cells. By treating these binding sites with specific chemical agents, they become less likely to release any substances into their surrounding environment when exposed to physiological conditions such as temperature changes or pH change. Additionally, this treatment removes unwanted components while preserving the desired component(s), resulting in increased purity levels in the final product.

Problems solved by technology

This patented technical problem addressed in this patents relates to improving the safety and efficacy of biological therapies like Immunosuppressive Aglycemabidum®(infusion adjuvants) and Interferon beta-1β Receptor Binding Protein-23. While these new agents were developed based upon traditional methods involving extraction from animal sources they did not fully address all issues involved in producing pure samples without contaminating certain substances called Factor VIII (fibrillary hemocytes)-related proteins.

Method used

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  • Preparation method of plasma human immunoglobulin

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] (1) Plasma to remove cryoprecipitate.

[0043] (2) Adsorption on DEAE Sephadex A50 gel. Collect the flow-through plasma and washing solution, which is the plasma after A50 adsorption. The eluate was used to prepare PCC product.

[0044] The Zeta Plus 60ZB adsorption material was washed with water for injection, and then washed with 100mM NaCl, 20mM NaCl 2 HPO 4 , pH6.5 solution cleaning, the dosage is 50L / m 2 ; After washing, drain and dry the adsorption material with compressed air, and then perform impurity adsorption on the plasma after A50 gel adsorption.

[0045] After the plasma was filtered through a 0.2 μm filter element, fixed-bed affinity chromatography was carried out through a chromatographic column packed with Capto Heparin affinity gel. The chromatographic column is treated with an equilibrium solution containing disodium hydrogen phosphate 10mmol / L, sodium chloride 0.3mol / L, and pH6.50, and the amount of each sample is controlled to be 30 column bed ...

Embodiment 2

[0056] (1) Plasma to remove cryoprecipitate.

[0057] (2) Plasma that has not been adsorbed by A50 gel directly enters the next step (3) for processing.

[0058] (3) Precipitation of FI+FII+FIII, adsorption of impurities, and reconstitution.

[0059] (4) FII precipitation, impurity adsorption, and redissolution.

[0060] (5) Use Zeta Plus 30ZB and 60ZB adsorption materials for overlapping use; use water for injection to clean the adsorption materials, and then use 5mM Na 2 HPO 4 , pH6.5 solution to clean the adsorption material, the dosage is 50L / m 2 ; After washing, drain the solution in the equipment and dry the adsorption material with compressed air, and then perform impurity adsorption on the supernatant after reconstitution of FII prepared from plasma that has not been adsorbed by A50 gel.

[0061] The supernatant after impurity adsorption, was filtered through a 0.2 μm filter element, and packed with Fractogel ® The chromatographic columns of EMDTMAE gel and Capto...

Embodiment 3

[0068] (1) Plasma to remove cryoprecipitate.

[0069] (2) Plasma that has not been adsorbed by A50 gel directly enters the next step (3) for processing.

[0070] (3) Precipitation of FI+FII+FIII, adsorption of impurities, and reconstitution.

[0071] (4) FII precipitation, impurity adsorption, and redissolution.

[0072] (5) Zeta Plus 30ZB and Zeta Plus 90ZB adsorption materials are used superimposed; wash with water for injection, and then use 15mM Na 2 HPO 4 , pH7.5 solution for cleaning, the dosage is 50L / m 2 ; After washing, drain the solution in the equipment and dry the adsorption material with compressed air, and then perform impurity adsorption on the supernatant after reconstitution of FII prepared from plasma that has not been adsorbed by A50 gel.

[0073] The supernatant after impurity adsorption was filtered through a 0.2 μm filter element, and fixed-bed chromatography was performed using a chromatographic column filled with DEAE Sepharose Fastflow gel. The ch...

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Abstract

The invention discloses a preparation method of plasma human immunoglobulin. The preparation method includes the steps: (1) performing plasma removal and cryoprecipitation; (2) adsorbing impurities inplasma adsorbed by DEAE (diethyl-aminoethanol) Sephadex A50 gel, and performing Heparin affinity chromatography to enter next treatment, and directly treating the plasma not subjected to the DEAE Sephadex A50 gel in a next step; (3) performing FI+FII+FIII precipitation, impurity adsorption and redissolving; (4) performing FII precipitation, impurity adsorption and redissolving; (5) performing impurity adsorption and chromatography on redissolved FII supernatant; (6) performing ultrafiltration concentration and sterilization preparation; (7) performing low-pH (potential of hydrogen) incubation. The purity of an immunoglobulin product produced by the preparation method is higher than or equal to 99%, no blood coagulation factors are detected, detection is performed by NaPTT and a developingsubstrate method, and FXI and FXIa contents of the final IgG product are below detection limit.

Description

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Claims

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Application Information

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Owner SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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