Preparation method for human immunoglobulin for intravenous injection

A technology of human immunoglobulin and intravenous injection, applied in the field of preparation of human immunoglobulin by intravenous injection, can solve the problem that the purity can only reach 95%, and achieve the advantages of shortening the production cycle, improving the product yield and improving the product yield. Effect

Active Publication Date: 2014-02-05
TONROL BIOLOGICAL PHARM CO LTD
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Problems solved by technology

In the process of separating out the precipitate of component III and the precipitate of component II, this method makes the amount of intravenously injected human immunoglobulin precipitated into the precipitate of III larger, and the product yield can only reach about 5.5 grams per liter of plasma, and the purity can only reach reach more than 95%

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  • Preparation method for human immunoglobulin for intravenous injection

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Embodiment 1

[0039] The plasma source of the present invention is human plasma conforming to the provisions of "Plasma for the Production of Biological Products" in the Pharmacopoeia of the People's Republic of China (2010 Edition).

[0040]It is the two-step filter press method of the present invention: get respectively 100 liters, 200 liters, 500 liters and 1000 liters of qualified human plasma, taking 100 liters of human plasma as an example.

[0041] (1) Centrifuge the human plasma that has passed the quarantine. During centrifugation, the centrifugation speed is 3L / min / unit, and the temperature of the liquid is controlled at 2°C; separate the cryoprecipitate, collect the protein solution into the reaction tank, and control the temperature of the protein solution at At 1°C, add pH4.0 acetate buffer at a flow rate of 0.1L / min to adjust the pH of the protein solution to 7.2; add -17°C 95% ethanol at a flow rate of 60L / h to make the final concentration of ethanol volume ratio to 8%, and co...

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Abstract

The invention discloses a preparation method for human immunoglobulin for intravenous injection. The preparation method comprises the following steps: (1) two-step filtering pressing: separating II+III precipitate from human plasma as a starting raw material, removing component III precipitate through low-temperature ethanol filter pressing, collecting supernatant, performing ultrafiltration and dialysis to the supernatant, and regulating the protein concentration; (2) two-step chromatography: performing upper column chromatography purification through a DEAF-Sepharose-FF ion exchange column, and collecting a first-step flow penetration liquid; performing ultrafiltration and dialysis to the collected first-step flow penetration liquid, regulating and performing chromatographic purification by using a Fractogel-EMD-TMA ion exchange column, and collecting a second-step flow penetration liquid; (3) performing ultrafiltration, dialysis and liquid preparation to the collected second-step flow penetration liquid; (4) inactivating virus, disinfecting, filtering and subpackaging to obtain a product. The product prepared by using the method is higher in bioactivity, yield and purity.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a preparation method for intravenous injection of human immunoglobulin. Background technique [0002] The active ingredient of intravenous human immunoglobulin is protein, and more than 95% of it is immunoglobulin. Made from healthy human plasma, separated and purified by low-temperature ethanol protein separation method, anti-complement activity removed and virus inactivated. The usual production method is low temperature ethanol centrifugation (press filtration) method, the product yield is low, the purity is low, and the stability is not good. [0003] The existing process of intravenous injection of human immunoglobulin by low-temperature ethanol method uses low-temperature ethanol to treat the precipitation of component II+III. Fraction II is then subjected to a one-step chromatographic process. In the process of separating out the precipitate of component III and the pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/06C07K1/36C07K1/34C07K1/18
Inventor 邵恒波汪模正胡辉恒邓坤
Owner TONROL BIOLOGICAL PHARM CO LTD
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