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Virus inactivation method for solution of globulin

A virus inactivation and globulin technology, applied in the biological field, can solve the problems of no practical value and low protein recovery rate

Active Publication Date: 2010-12-29
国药集团武汉血液制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Prior art [referring to: Biologicals, 2003, 31 (3): 213-221.] The disclosed caprylate virus inactivation technical scheme is: caprylate 16mM, protein concentration 10%, pH value 4.5, temperature 35 ℃, After 1 hour, we conducted a condition reproduction test in the laboratory and tested the recovery rate. The test results showed that the protein recovery rate of this scheme was less than 10%, and the protein recovery rate was too low to be of practical value.
[0010] The requirement of recovery rate of blood products has always been the standard for the feasibility of various processes in the production of blood products. When the Bath inactivation method is used for virus inactivation of globulin solution, the protein recovery rate should not be lower than 33%, but the increasingly tense blood source The industry has not adopted the Bath inactivation method for globulin virus inactivation. Therefore, the technical solutions disclosed in the prior art have no practical value due to the low protein recovery rate

Method used

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  • Virus inactivation method for solution of globulin
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  • Virus inactivation method for solution of globulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] Take 400 ml of intravenous human immunoglobulin provided by Wuhan Institute of Biological Products, and determine the protein content with reference to the three parts of the "Pharmacopia of the People's Republic of China" 2005 edition Kjeldahl method. Test result: the protein content is 11.8%.

[0136] Inactivation parameters: sodium octanoate concentration 16mmol, protein solution to be inactivated 100ml, inactivation time 1.5 hours, inactivation temperature 30±1°C, sodium octanoate solution pH 8.5, pH 4.9 during inactivation, diluent 0.9% NaCl solution.

[0137] Inactivation step:

[0138] a. Calculate the consumption of sodium octanoate: the consumption of sodium octanoate is calculated according to the ratio of 16: 1 by the weight ratio (mmol / g) of protein in sodium octanoate and the protein in the virus inactivation globulin solution: 100ml * 11.8% * 166 * 16 / 1000=31.3 grams, take by weighing 31.3 grams of sodium caprylate; Add the sodium caprylate that takes by...

Embodiment 2

[0142] Take 400 ml of intravenous human immunoglobulin provided by Wuhan Institute of Biological Products, and determine the protein content with reference to the three parts of the "Pharmacopia of the People's Republic of China" 2005 edition Kjeldahl method. Test result: the protein content is 11.8%.

[0143] Inactivation parameters: sodium octanoate concentration 16mmol, protein solution to be inactivated 100ml, inactivation time 1.5 hours, inactivation temperature 30±1°C, sodium octanoate solution pH 5.5, pH 4.7 during inactivation, diluent 0.9% NaCl solution.

[0144] Inactivation step:

[0145] a. Calculate the consumption of sodium octanoate: the consumption of sodium octanoate is calculated according to the ratio of 16: 1 by the weight ratio (mmol / g) of protein in sodium octanoate and the protein in the virus inactivation globulin solution: 100ml * 11.8% * 166 * 16 / 1000=31.3 grams, take by weighing 31.3 grams of sodium octanoate, add the sodium octanoate that takes by...

Embodiment 3

[0149] Take 400 ml of intravenous human immunoglobulin provided by Wuhan Institute of Biological Products, and determine the protein content with reference to the three parts of the "Pharmacopia of the People's Republic of China" 2005 edition Kjeldahl method. Test result: the protein content is 11.8%.

[0150] Inactivation parameters: sodium octanoate concentration 16mmol, protein solution to be inactivated 100ml, inactivation time 1.5 hours, inactivation temperature 30±1°C, sodium octanoate solution pH 5.6, pH 4.8 during inactivation, diluent 0.9% NaCl solution.

[0151] Inactivation step:

[0152] a. Calculate the consumption of sodium octanoate: the consumption of sodium octanoate is calculated according to the ratio of 16: 1 by the weight ratio (mmol / g) of protein in sodium octanoate and the protein in the virus inactivation globulin solution: 100ml * 11.8% * 166 * 16 / 1000=31.3 grams, take by weighing 31.3 grams of sodium octanoate, add the sodium octanoate that takes by...

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Abstract

The invention provides a virus inactivation method for solution of globulin. An optimum proportion with a practical value of various parameters during virus inactivation with sodium caprylate is provided by a large number of researches on various conditions such as a temperature, a pH value, concentration of caprylate, concentration of protein and hatch time during the virus inactivation. Experiments prove that the virus inactivation method for the solution of the globulin has the advantages of simpleness, safety, rapidness, effectiveness, high protein recovery and no effect on the bioactivity of a target protein.

Description

technical field [0001] The invention belongs to the field of biotechnology and relates to virus inactivation technology, in particular to the virus inactivation technology in immunoglobulin solution of biological products. Background technique [0002] At present, the methods for inactivating viruses in immunoglobulin solutions include organic solvent / detergent method (S / D method), low pH method and D50 method. Table 1 below shows the virus inactivation effect and existence of various methods. lack of. [0003] Table 1: Virus inactivation effects and deficiencies of various methods [0004] [0005] When the Cohn method is used to separate immunoglobulins, the conditions of ethanol and low temperature have the effect of inhibiting, clearing and killing pathogenic microorganisms, but this effect is extremely limited, so it cannot be used as a virus inactivation method. [0006] When the Bath inactivation method is used for globulin virus inactivation, the recovery rate i...

Claims

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Application Information

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IPC IPC(8): A61L2/18C07K16/00C07K1/34A61L101/42
Inventor 邹莉李策生彭良俊叶巨兵张智彭焱缪燕敏方舸纽泽春
Owner 国药集团武汉血液制品有限公司
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