Double virus inactivating/removing method for venous injection human immune globulin

A technology of immunoglobulin and virus, which is applied in the field of preparation of human plasma protein, can solve the problems of aggregation and loss of biological activity, poor inactivation effect of non-lipid enveloped virus, difficulty in adopting immunoglobulin, etc., and achieve the effect of safe use

Inactive Publication Date: 2003-11-26
CHENGDU RONGSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The virus inactivation methods commonly used in the production of plasma protein products include heat inactivation (such as pasteurization of albumin) and SD inactivation methods. Due to the characteristics of immunoglobulins in biological structure and function, the above two virus inactivation methods The method is easy to lead to the aggregation of its IgG and the loss of biological activity, so it is difficult to

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] The first step of low pH incubation treatment: take F II Precipitate 20 kg, dissolve with 160 liters of water for injection at 0°C, adjust the pH to 4.0 with 1mol / L hydrochloric acid, filter with a plate and frame filter, concentrate with water for injection, 100kD ultrafiltration membrane, dialyze until the residual ethanol content is ≤0.03%, add 9 % maltose, adjust the protein concentration to 5.0%, pH to 4.2, sterilize and filter with 0.2 μm membrane, pack into 10 liter glass bottles, place at 24°C and incubate for 21 days to obtain semi-finished immunoglobulin.

[0015] The second step of nanofiltration: After the immunoglobulin semi-finished product that has been incubated at low pH is qualified, it is filtered with a 35nm BMM membrane (Asahi Kasei, Japan) in series with a 0.2μm sterile filter membrane at a temperature of 20-30°C and a pressure of 30-100Kpa. , and finally dispensed into vials (1.25g / bottle or 2.5g / bottle), and conducted a comprehensive quality insp...

Embodiment 2

[0017] The first step of low pH incubation treatment: take F II Precipitate 25 kg, dissolve with 200 liters of water for injection at 0°C, adjust the pH to 4.0 with 1mol / L hydrochloric acid, filter with a plate and frame filter, concentrate with water for injection, 100kD ultrafiltration membrane, dialyze until the residual ethanol content is ≤0.03%, add 10 % maltose, adjust the protein concentration to 5.0%, pH to 4.2, sterilize and filter with 0.2 μm membrane, pack into 11 liter glass bottles, place at 24°C and incubate for 21 days to obtain semi-finished immunoglobulin.

[0018] The second step of nanofiltration: After the immunoglobulin semi-finished product that has been incubated at low pH is qualified, it is filtered with a 25nm BMM membrane (Asahi Kasei, Japan) in series with a 0.2μm sterile filter membrane at a temperature of 20-30°C and a pressure of 30-100Kpa. , and finally dispensed into vials (1.25g / bottle or 2.5g / bottle), and conducted a comprehensive quality ins...

Embodiment 3

[0020] The first step of low pH incubation treatment: take F II Precipitate 22 kg, dissolve with 176 liters of water for injection at 0°C, adjust the pH to 4.0 with 1mol / L hydrochloric acid, filter with a plate and frame filter, concentrate with water for injection, 100kD ultrafiltration membrane, dialyze until the residual ethanol content is ≤0.03%, add 10 % maltose, adjust the protein concentration to 4.5%, pH to 4.2, 0.2 μ membrane sterilizing filter, pack into 10 liter glass bottles, and place it at 24°C for 21 days to obtain semi-finished immunoglobulin.

[0021] The second step of nanofiltration: After the immunoglobulin semi-finished product that has been incubated at low pH is qualified, it is filtered with a 15nm BMM membrane (Asahi Kasei Japan) in series with a 0.2μm sterile filter membrane at a temperature of 20-30°C and a pressure of 30-100Kpa. , and finally dispensed into vials (1.25g / bottle or 2.5g / bottle), and conducted a comprehensive quality inspection accordi...

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Abstract

The present invention relates to the preparation process of human plasma protein, and is especially the double virus inactivating/removing process for preparing venous injected human immune globulin. The preparation process of human plasma immune globulin includes low temperature alcohol separation to obtain precipitated component II, low pH treatment to inactivate virus, and nanometer membrane filtering to eliminate virus. The present invention has no loss of IgG bioactivity while eliminating virus, so that the venous injected human immune globulin is even safe for clinical application.

Description

technical field [0001] The invention relates to a preparation method of human plasma protein, in particular to a preparation method for intravenous injection of human immunoglobulin by adopting a double virus inactivation / removal method. Background technique [0002] The production of immunoglobulin has a history of more than half a century. From the 1960s to the early 1980s, it was generally believed that immunoglobulins prepared through low-temperature ethanol separation did not transmit viral diseases. With the advent of intravenous immunoglobulin (IVIG) in the early 1980s, clinically significant results have been achieved in the treatment of primary or secondary immunodeficiency and some autoimmune diseases. IVIG is recognized as a safe and effective products. However with Lane [1] After the first report of non-A, non-B hepatitis transmission following IVIG infusion in 1983, the viral safety of IVIG attracted attention. Since Lane's report, thousands of cases of non-A...

Claims

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Application Information

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IPC IPC(8): A61K39/395C07K1/34C07K16/18
Inventor 王玉廖红茹鲁涛吕家成郭中平
Owner CHENGDU RONGSHENG PHARMA
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