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Production process of blood-derived human blood coagulation factor VIII/von willebrand factor compound

A technology of human coagulation factor and hemophilia factor, which is applied in the direction of coagulation/fibrinolytic factor, VII factor, animal/human protein, etc., can solve problems such as complex process, maintain binding ability, prevent titer attenuation, prevent activated effect

Active Publication Date: 2022-03-01
SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Aiming at the technical problems of complex production process of existing FⅧ / VWF complex and the introduction of exogenous substances, the present invention provides a production process of blood-derived human coagulation factor VIII / von Willebrand factor complex, from plasma to The finished product only needs two steps of centrifugation, one step of chromatography, and one step of ultrafiltration. The process steps are simple, and no foreign substances such as aluminum hydroxide, PEG, etc. that are not contained in the human body are introduced.

Method used

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  • Production process of blood-derived human blood coagulation factor VIII/von willebrand factor compound
  • Production process of blood-derived human blood coagulation factor VIII/von willebrand factor compound
  • Production process of blood-derived human blood coagulation factor VIII/von willebrand factor compound

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Experimental program
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Effect test

Embodiment 1

[0060] Such as figure 1 As shown, a FⅧ / VWF complex production process includes the following steps:

[0061] (1) Preparation of cryoprecipitate from plasma, dissolution of cryoprecipitate, and removal of crude impurities

[0062] Plasma cryoprecipitate was prepared by centrifugation with a centrifugal force of 5500g. 50kg of cryoprecipitate was stirred and dissolved with 100kg of water for injection containing 1U / ml heparin at 35°C. Use 0.1mol / L acetic acid to adjust the pH value of the solution to 6.90, the conductivity to 3.8mS / cm, stir at 25°C to keep the insoluble matter in the product in a suspended state, and incubate for 1 hour. After the incubation, adjust the temperature of the product to 15°C. 0.1mol / L acetic acid to adjust the pH value of the product to 6.50, the pH adjustment process takes 1 hour, stir to keep the acid precipitate in a suspended state, and incubate for 3 hours. The acid precipitate is separated by centrifugation with a centrifugal force of 5500g...

Embodiment 2

[0087] Such as figure 1 As shown, a FⅧ / VWF complex production process includes the following steps:

[0088] (1) Preparation of cryoprecipitate from plasma, dissolution of cryoprecipitate, and removal of crude impurities

[0089]Plasma cryoprecipitate was prepared by centrifugation at a centrifugal force of 1000g. 50kg of cryoprecipitate was stirred and dissolved with 150kg of water for injection containing 1U / ml heparin at 35°C. Use 0.1mol / L acetic acid to adjust the pH value of the solution to 6.60, the conductivity to 3.2mS / cm, stir at 25°C to keep the insoluble matter in the product in a suspended state, and incubate for 1 hour. After the incubation, adjust the temperature of the product to 15°C. 0.1mol / L acetic acid was used to adjust the pH value of the product to 6.30. The pH adjustment process took 3 hours, stirred to keep the acid precipitate in a suspended state, and incubated for 3 hours. The acid precipitate was separated by centrifugation, centrifugal force 100...

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Abstract

The invention relates to the technical field of blood products, in particular to a blood-source human blood coagulation factor VIII / von willebrand factor compound production process which comprises the following steps: (1) preparing cryoprecipitate from plasma, dissolving the cryoprecipitate and removing crude impurities; (2) product amino acid protection incubation; (3) S / D virus inactivation; (4) ion exchange chromatography: incubating a chromatographic filler by using a solution containing protective components before loading; (5) ultrafiltration preparation; and (6) sub-packaging, freeze-drying and dry-heating. According to the production process, only two steps of centrifugation, one step of chromatography and one step of ultrafiltration are needed from plasma to a finished product, the process steps are simple, and aluminum hydroxide, PEG and other allogenic substances which are not contained in a human body are not introduced; the purity of the product is effectively improved through amino acid protection in the incubation step and the chromatography step after cryoprecipitation dissolution and crude impurity removal.

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 / von Willebrand factor complex. Background technique [0002] Plasma-derived human coagulation factor VIII / von Willebrand factor complex is a plasma protein component obtained by separating and purifying plasma from healthy people, and contains human coagulation factor VIII (Coagulation Factor VIII, FVIII) and human vascular coagulation factor VIII Hemophilia factor (von Willebrand Factor, VWF). [0003] The FⅧ / VWF complexes approved by the U.S. Food and Drug Administration are Alphanate, Wilate, and Humate-P, which can be used for hereditary hemophilia A (Hemophilia A, HA) and VWF deficiency or deficiency caused by FⅧ deficiency or deficiency The treatment of von Willebrand Disease (VWD) caused by it. Among the above products, the production process of Alphanate is to prepare cryoprecipitate by centrifug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/755C07K1/36C07K1/34C07K1/18C07K1/14
CPCC07K14/755Y02A50/30
Inventor 刘文杰杨西建郭全娟徐一轲史文强高建锋马杰刘坤陈振周安菅长永
Owner SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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