Method for effectively removing human immune globulin polymer

A human immunoglobulin and multimer technology, applied in the field of biopharmaceuticals, can solve problems such as reducing human immunoglobulin multimers

Active Publication Date: 2015-02-18
BEIHAI KAIYUAN BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among the currently published separation methods of intravenous injection of human immunoglobulin, the patents related to the precipitation of sodium octanoate (CN95109051.8, CN201210041098, CN201210071691, CN2...

Method used

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  • Method for effectively removing human immune globulin polymer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] 1. After the FII solution is dealcoholized by ultrafiltration, the protein content of the protein solution is adjusted to 4-7g / L, and the pH value of the solution is adjusted to 5.35-5.55.

[0016] 2. Add 1mol / L sodium octanoate to make the final sodium octanoate content reach 6-8mmol / L, add at a speed of 10-15L / h, stir for more than 4 hours after completion, retest the pH value of the solution to 5.35-5.55, otherwise use pH4.0 Acetate buffer was adjusted to this range. The temperature is controlled at 15-25°C.

[0017] 3. Use 7mmol / L sodium octanoate balance solution (containing sodium octanoate 7mmol / L, sodium chloride: 1.25g / L, pH5.35~5.55, temperature 15℃~25.0℃) 400~600L, add diatomaceous earth 4Kg The upper filter plate of the filter press is cleaned cyclically, and after cleaning, it is pressed and filtered, and the outlet temperature is 10°C to 15°C. After pressing the filter, dry the filter plate with pre-cooled clean air for 30-40 minutes. Wash the filter pl...

Embodiment 2

[0022] 1. The pasteurized inactivated protein solution was continuously dialyzed with equal volume of water for injection at 2-8°C to a conductivity of 100μs / cm 2 Below, the protein content is concentrated to 10g / L. Adjust the protein content of the protein solution to 4-7g / L, and adjust the pH value of the solution to 5.35-5.55 with pH4.0 acetate buffer or 0.5mol / L sodium hydroxide.

[0023] 2. The following steps are the same as steps 2, 3, and 4 in Example 1.

[0024] step Example 1 No polymer removal step added Polymer content of protein solution after dealcoholization (%) 9.43% 9.43% Polymer content after press filtration (%) 2.73% / Finished polymer content (%) 2.74% 10.11% Yield of human immunoglobulin (g / ㎏FII) 206 219

Embodiment 3

[0026] Place the sample in an environment of 2-8°C, and measure its multimer data. The measurement method adopts "Chinese Pharmacopoeia" Three Volumes 2010 Edition Appendix VI R Human Immunoglobulin Products Monomer Plus Dimer Determination Method, the results are as follows :

[0027] time sample 1 sample 2 0 month 1.63% 2.74% March 1.62% 2.74% June 1.68% 2.76% September 1.71% 2.80% December 1.77% 2.78% 24 months 1.85% 2.79%

[0028] As can be seen from the measurement of the above-mentioned reserved samples, the product obtained by the method of the present invention has stable sample quality and stable multimer content.

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Abstract

The invention discloses a method for effectively removing human immune globulin polymer. The operation of reducing polymer in an immune globulin purification process is necessary. A polyethylene glycol method and a column chromatography which can remove human immune globulin polymer are reported in public at present, but the two methods have problems of being difficult in removing additives, small in handling capacity and expensive in equipment, and the popularization and application are difficult. The method comprises the following steps: by using a sodium caprylate precipitation method, precipitating to remove IgG polymer under the condition that the solution pH value is 5.4 and the caprylate concentration is 6-8mmol/L, wherein more than 60% of polymer can be effectively removed so that the polymer can be reduced to 3% or below, the loss of the immune globulin is little, the polymer content is stable, and the polymer content can achieve requirement of Chinese pharmacopoeia and Foreign related pharmacopoeia after being placed for two years.

Description

[0001] technical field [0002] The invention relates to the field of biopharmaceuticals, in particular to a method for effectively removing human immunoglobulin multimers. Background technique [0003] Immunoglobulins are a group of proteins with antibody activity, which are divided into five classes: IgG, IgA, IgM, IgD, and IgE. After infusion, it can rapidly increase the IgG level in the recipient's blood, and enhance the body's anti-infection ability and immune regulation function. Most of the publicly reported human immunoglobulin extraction methods use the low-temperature ethanol fractionation precipitation technology created by Professor E.J. Cohn, or combine one-step or multi-step ion exchange layer systems on the basis of Cohn’s process fractionation, or combine caprylic acid precipitation-chromatography to achieve purification Most of the virus inactivation methods adopt the classic pasteurization method, organic solvent method, low pH incubation method, etc. But...

Claims

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Application Information

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IPC IPC(8): C07K16/00C07K1/30
Inventor 莫丽影吴志捷袁小琴
Owner BEIHAI KAIYUAN BIOLOGICAL TECH
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