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Preparation method of cold sediment and application of cold sediment to production of human coagulation factor VIII

A technology of human coagulation factor and cryoprecipitation, which is applied in the fields of biopharmaceuticals and blood products, can solve the problems of attenuation of cryoprecipitated human coagulation factor VIII activity and long plasma melting time, so as to protect the activity of factor VIII, reduce the melting time and control the activity Attenuation effect

Inactive Publication Date: 2018-12-11
广东双林生物制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the plasma thawing time of the conventional thawing centrifugation method is too long, and the activity of the prepared cryoprecipitated human coagulation factor VIII is severely attenuated.
[0006] At the same time, the quality of plasma determines the quality of cryoprecipitate, and controlling the activity attenuation of plasma raw materials is of great significance for reducing the activity loss of cryoprecipitate factor VIII from the source, but less attention has been paid to this in previous researches on cryoprecipitate preparation technology

Method used

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  • Preparation method of cold sediment and application of cold sediment to production of human coagulation factor VIII
  • Preparation method of cold sediment and application of cold sediment to production of human coagulation factor VIII
  • Preparation method of cold sediment and application of cold sediment to production of human coagulation factor VIII

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Effect test

Embodiment 1

[0033] [embodiment 1] the preparation of cryoprecipitate of the present invention

[0034] (1) Quick-freezing of fresh human plasma: After a single bag of 600g fresh plasma is collected, it is completely frozen within 30 minutes with a blower-type continuous quick-freezing device at -30°C until there is no fluid liquid, and stored in a freezer below -20°C to ensure that the plasma activities of various protein components.

[0035] (2) Transportation of frozen human plasma raw materials: Plasma transportation was carried out by a fully automatic temperature-controlled refrigerated transport vehicle, and the temperature was automatically recorded every 30 minutes during the transportation process. After the transportation arrived, it was immediately transferred to a -20°C cold storage for storage.

[0036] (3) Frozen human plasma raw material thawing: Take 1600 bags of frozen human plasma raw material stored in a -20°C freezer for one year, and place the frozen human plasma raw ...

Embodiment 2

[0040] [embodiment 2] the preparation of cryoprecipitate of the present invention

[0041] (1) Quick-freezing of fresh human plasma: After a single bag of 600g fresh plasma is collected, it is completely frozen within 30 minutes with a blower-type continuous quick-freezing device at -30°C until there is no fluid liquid, and stored in a freezer below -20°C to ensure that the plasma activities of various protein components.

[0042](2) Transportation of frozen human plasma raw materials: Plasma transportation was carried out by a fully automatic temperature-controlled refrigerated transport vehicle, and the temperature was automatically recorded every 30 minutes during the transportation process. After the transportation arrived, it was immediately transferred to a -20°C cold storage for storage.

[0043] (3) Frozen human plasma raw material thawing: Take 3200 bags of frozen human plasma raw material stored in a -20°C freezer for one year, and place the frozen human plasma raw m...

Embodiment 3

[0047] [Example 3] The cryoprecipitate prepared by the present invention is used to produce human coagulation factor VIII

[0048] With cryoprecipitate prepared by the present invention as raw material, human coagulation factor VIII is produced as follows:

[0049] Cryoprecipitate dissolved (water for injection: 1~5L / kg cryoprecipitate, heparin sodium injection: 1~15IU / g water for injection, pH: 7.0±0.5, temperature: 15~25℃);

[0050] Aluminum glue adsorption (1~3%Al(OH) 3 Gel: 108g~1080g / kg cryoprecipitate), adjust pH to 6.5±0.5 with 0.1mol / L acetic acid, and centrifuge (outlet temperature: 10~25℃);

[0051] Filter the supernatant and adjust the filtrate (pH: 7.0±0.5, temperature: 15-25°C);

[0052] S / D virus inactivation (1%±0.3%Tween-80, 0.3%±0.06%TNBP, 25~26℃, 8h);

[0053] After filtration, ion exchange chromatography, ultrafiltration, dialysis, liquid preparation and subpackaging, human blood coagulation factor VIII products are finally obtained.

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Abstract

The invention discloses a preparation method of cold sediment and application of cold sediment to production of a human coagulation factor VIII. The preparation method comprises the following steps: (1) quickly freezing blood plasma: after collecting the blood plasma, freezing and molding through a low-temperature quick-freezing technology; (2) transporting the blood plasma; (3) melting the bloodplasma: pre-heating at -5 to -3 DEG C and treating for 24 to 36 hours; then melting the blood plasma at the constant temperature of 0 to 4 DEG C until the blood plasma is completely melted; (4) mixingthe blood plasma and standing: mixing the blood plasma under mild stirring; standing for 4 to 8 hours at the constant temperature of 0 to 4 DEG C; (5) centrifuging the blood plasma: continuously centrifuging the blood plasma at low temperature to prepare the cold sediment. According to the preparation method disclosed by the invention, the activity of the factor VIII in the blood plasma is effectively protected through the low-temperature quick-freezing technology, and the activity loss of the factor VIII is reduced by 30 percent or more when being compared with the activity loss of a conventional method. The cold sediment is used as a raw material to produce a human coagulation factor VIII product with high potency and high specific activity; the potency of the obtained product is greater than 80 percent and the specific activity of the product reaches 90IU / mg or more.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals and blood products, and specifically relates to a method for preparing plasma cryoprecipitate with high yield and low activity loss in the production of blood products and the application of the cryoprecipitate prepared by the method in the production of human blood coagulation factor VIII. Background technique [0002] Human coagulation factor Ⅷ (FⅧ) product is a plasma protein product isolated and purified from healthy human plasma, which has a corrective effect on coagulation dysfunction caused by the lack of human coagulation factor Ⅷ, and is mainly used to prevent and treat hemophilia A And the bleeding symptoms caused by the deficiency of coagulation factor Ⅷ and the treatment of surgical bleeding in such patients. At present, there are not many manufacturers capable of producing human coagulation factor Ⅷ in my country, and the raw material plasma is in short supply, resulting in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/755C07K1/14
CPCC07K14/755
Inventor 朱光祖
Owner 广东双林生物制药有限公司
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