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A kind of production process of blood-derived human blood coagulation factor VIII

A technology of human blood coagulation factor and production process, which is applied in the direction of blood coagulation/fibrinolytic factor, VII factor, animal/human protein, etc., can solve the problems of limited yield capacity of FVIII products, and achieve convenient process upgrading, efficient recovery, and cost saving The effect of rate loss

Active Publication Date: 2022-05-27
SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that under the conditions of the existing technological process, the ability to improve the yield of FVIII products is limited

Method used

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  • A kind of production process of blood-derived human blood coagulation factor VIII
  • A kind of production process of blood-derived human blood coagulation factor VIII
  • A kind of production process of blood-derived human blood coagulation factor VIII

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] A process for producing blood-derived human coagulation factor VIII,

[0052] (1) Plasma preparation cryoprecipitate, cryoprecipitate dissolution, impurity removal

[0053] Plasma was cryoprecipitated by centrifugation. 100kg of cryoprecipitate was dissolved with 300kg of water for injection at 35°C with stirring. The pH value of the solution was adjusted to 6.6 with 0.1 mol / L acetic acid, and the conductivity was 3.2 mS / cm. A balanced DEAE Sephadex A50 gel was added, and the amount of the A50 gel was 150 g dry gel. After stirring and adsorbing for 45 minutes, the gel and undissolved precipitate were removed by centrifugation; the supernatant after centrifugation was adjusted to pH 6.3 with 0.1 mol / L acetic acid, and the temperature was lowered to 15°C, and the precipitate was separated by centrifugation. FVIII remained in the supernatant.

[0054] (2) S / D virus inactivation

[0055] The supernatant after centrifugation was clarified and filtered through a 0.2 μm f...

Embodiment 2

[0075] A process for producing blood-derived human coagulation factor VIII,

[0076] (1) Plasma preparation cryoprecipitate, cryoprecipitate dissolution, impurity removal

[0077] Plasma was cryoprecipitated by centrifugation. 100kg cryoprecipitate was dissolved by stirring at 25°C with 300kg water for injection. The pH value of the solution was adjusted to 7.0 with 0.1 mol / L acetic acid, and the conductivity was 3.1 mS / cm. A balanced DEAE Sephadex A50 gel was added, and the amount of the A50 gel was 180 g dry gel. After stirring and adsorbing for 45 minutes, the gel and undissolved precipitate were removed by centrifugation; the supernatant after centrifugation was adjusted to pH 6.2 with 0.1 mol / L acetic acid, and the temperature was lowered to 12 °C, and the precipitate was separated by centrifugation. FVIII remained in the supernatant.

[0078] (2) S / D virus inactivation

[0079] The supernatant after centrifugation was clarified and filtered through a 0.2 μm filter e...

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PUM

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Abstract

The invention discloses a production process of blood-derived human blood coagulation factor VIII. After performing S / D virus inactivation, perform ion exchange chromatography twice, collect the washing solution, and combine the two elution peak solutions to prepare the product. The production loss of FVIII is effectively reduced by re-chromatographically recovering the FVIII in the washing solution of the first ion exchange chromatography. During the first chromatographic process, the content of FVIII in the washing liquid usually accounts for 10%-30% of the FVIII in the solution after S / D inactivation. Through the second chromatography, the complete recovery of FVIII in the washing solution of the first chromatography can be basically achieved.

Description

technical field [0001] The invention relates to the technical field of blood products, in particular to a production process of blood-derived human coagulation factor VIII. Background technique [0002] Human coagulation factor VIII (Human Coagulation Factor VIII, FVIII) is an important factor in the endogenous coagulation pathway in the human body. Its function is to act as a cofactor of coagulation factor IXa and participate in the activation of coagulation factor X, thereby promoting coagulation in the human body. cascade reaction. FVIII deficiency can lead to a blood clotting disorder in the body called hemophilia A. The main reason is that the coagulation factor VIII encoding gene mutation in vivo leads to the defect of the coagulation factor function, which leads to coagulation dysfunction. The symptoms are inherited in an X-linked recessive manner, transmitted by females, and occur in males, with an incidence of about 1 / 5000 males, and female patients are extremely ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/755C07K1/18
CPCC07K14/755
Inventor 周安杨西建刘文杰马杰高建锋刘坤陈振菅长永马山
Owner SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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