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A preparation process for intravenous injection of human immunoglobulin

A human immunoglobulin and preparation process technology, applied in the field of biopharmaceuticals, can solve the problems of affecting the biological activity of intravenously injected human immunoglobulin, affecting the safety of clinical use of the product, and the inability to effectively remove viruses, so as to improve the appearance of the product, improve the Product safety, loss reduction effect

Active Publication Date: 2022-04-26
GUIZHOU TAIBANG BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, in the preparation process of intravenous human immunoglobulin, S / D is often used to inactivate (some foreign blood product companies choose to inactivate the virus for 6 hours at 30°C), or use nano-membrane filtration to remove the virus, However, the S / D inactivation takes a long time and the effect is relatively general, which is likely to affect the biological activity of intravenously injected human immunoglobulin. When using nano-membrane filtration to remove viruses, some viruses cannot be effectively removed, which affects the safety of clinical use of the product.

Method used

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  • A preparation process for intravenous injection of human immunoglobulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] (1) Take 1kgCohn component I+II+III / II+III as raw material;

[0034] (2) Dissolve Cohn component I+II+III / II+III with 10 times water for injection, adjust pH=4.0 with acetic acid, and press filter to get the filtrate;

[0035] (3) in filtrate, add octanoic acid to make filtrate concentration be 20mmol / L, regulate filtrate pH to 4.8 with NaOH, add filter aid, press filtration;

[0036] (4) Adjust the pH of the filtered filtrate to 4.0, and incubate at 37° C. for 9 hours;

[0037] (5) The filtrate after hatching is first carried out EMD DEAE chromatography, then carries out EMD TMAE chromatography, controls two chromatography speeds 150cm / h, during DEAE chromatography, the pH of solution is adjusted 5.1, during TMAE chromatography, solution Adjust to a pH of 5.9, and maintain a conductivity of 1.8mS / cm during two chromatographic runs;

[0038] (6) collect the flow-through liquid through two chromatography, carry out ultrafiltration dialysis concentration;

[0039] (7) ...

Embodiment 2

[0043] (1) Take 1kgCohn component I+II+III / II+III as raw material;

[0044] (2) Dissolve Cohn component I+II+III / II+III with 8 times water for injection, adjust pH=3.8 with acetic acid, and take the filtrate by deep filtration;

[0045] (3) in filtrate, add octanoic acid to make filtrate concentration be 20mmol / L, regulate filtrate pH to 4.8 with NaOH, add filter aid, press filtration;

[0046] (4) Adjust the pH of the filtered filtrate to 4.0, and incubate at 37° C. for 6 hours;

[0047] (5) The filtrate after hatching is first carried out EMD DEAE chromatography, then carries out EMD TMAE chromatography, controls twice chromatography speed 100cm / h, during DEAE chromatography, solution is adjusted to the pH of 4.8, and during TMAE chromatography, solution Adjust to a pH of 5.6, and maintain a conductivity of 1.6mS / cm during two chromatography;

[0048] (6) collect the flow-through liquid through two chromatography, carry out ultrafiltration dialysis concentration;

[0049]...

Embodiment 3

[0053] (1) Take 1kgCohn component I+II+III / II+III as raw material;

[0054] (2) Dissolve Cohn component I+II+III / II+III with 12 times water for injection, adjust pH=4.2 with acetic acid, and take the filtrate by deep filtration;

[0055] (3) in filtrate, add octanoic acid to make filtrate concentration be 20mmol / L, regulate filtrate pH to 4.8 with NaOH, add filter aid, press filtration;

[0056] (4) Adjust the pH of the filtered filtrate to 4.0, and incubate at 37° C. for 12 hours;

[0057] (5) The filtrate after hatching is first carried out EMD DEAE chromatography, then carries out EMD TMAE chromatography, controls twice chromatography speed 200cm / h, during DEAE chromatography, the pH of solution adjustment 5.4, during TMAE chromatography, solution Adjust to a pH of 6.2, and maintain a conductivity of 2.0 mS / cm during two chromatography;

[0058] (6) collect the flow-through liquid through two chromatography, carry out ultrafiltration dialysis concentration;

[0059] (7) ...

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Abstract

The invention relates to the field of medicine, in particular to a preparation process for intravenous injection of human immunoglobulin. The present invention uses octanoic acid instead of ethanol as a precipitant to precipitate acidic proteins in plasma, while IgG molecules with a higher isoelectric point remain in the supernatant, and can be transferred to the chromatography process with only one step of precipitation reaction; octanoic acid is used Salt can inactivate lipid-enveloped viruses and even some non-lipid-enveloped viruses in a relatively short period of time under relatively mild conditions. The action time is short and the effect is good. It is not easy to affect the biological activity of immunoglobulins and improve product safety. High stability, ensuring the quality and yield of the product; using a two-step chromatography process to remove most polymers and other impurity proteins, reduce pyrogens, and also adsorb colored proteins such as ceruloplasmin, effectively improving the appearance of the product Adopt one-step precipitation reaction, reduce loss and increase product yield, which is a preparation process for intravenous injection of human immunoglobulin with high product yield and purity and good safety.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a preparation process for intravenous injection of human immunoglobulin. Background technique [0002] Human immunoglobulin (Immunoglobulin, Ig) is the main substance of the human body's immune response to foreign antigens (such as bacteria, viruses and their toxins or foreign substances), also known as antibodies. Immunoglobulins can be divided into 5 categories according to their structures, named IgG, IgA, IgM, IgD and IgE respectively. Among them, IgG has the highest content, accounting for about 70-80% of the total serum immunoglobulins, and is an important plasma immunoglobulin. one of protein. The content in plasma is about 6.6-14.5g / L. IgG is mainly synthesized by plasma cells in the spleen and lymph nodes. It is composed of four peptide chain molecules, and the peptide chains are connected by disulfide bonds. The relative molecular mass is 150kD. [0003] The active i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K16/00C07K1/36C07K1/34C07K1/18
CPCC07K16/00
Inventor 陈云华刘勇容伟张尧邓靖赵学梅刘欣晏杨刚
Owner GUIZHOU TAIBANG BIOLOGICAL PROD
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