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Preparation method of freeze-dried human blood coagulation factor VIII

A human coagulation factor and freeze-drying technology, which is applied in the preparation method of peptides, coagulation/fibrinolytic factors, factor VII, etc., can solve the problems of lack of plasma resources, scientific research technology, long reconstitution time, limited quantity, etc., and achieve the goal of improving plasma The effect of resource utilization, improving purity and specific activity, and alleviating medication tension

Pending Publication Date: 2020-12-04
哈尔滨派斯菲科生物制药有限公司
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The number of domestic blood product companies that can produce human coagulation factor VIII products is limited, and due to the serious shortage of plasma resources and the backwardness of scientific research technology, there has been a huge gap in the clinical supply of domestic FⅧ for a long time, and the hemophilia patients who can receive formal treatment in my country less than 10%
With the improvement of people's living standards and the popularization of testing and screening, the huge market gap is difficult to fill in the short term
[0004] The current commercially available human coagulation factor VIII preparations have low specific activity and excessive exogenous pollutants that affect the safety of the product
Most of the processes are prepared by aluminum hydroxide adsorption and PEG precipitation, such as CN20140496187.9 "A Preparation Method for Human Blood Coagulation Factor VIII", using Al(OH) 3 The gel is adsorbed, resulting in the product containing Al 3+ The residue of ions affects the safety of the product, and there are problems of poor stability, long reconstitution time, low specific activity, and high loss rate

Method used

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  • Preparation method of freeze-dried human blood coagulation factor VIII
  • Preparation method of freeze-dried human blood coagulation factor VIII
  • Preparation method of freeze-dried human blood coagulation factor VIII

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preparation example Construction

[0097] Such as figure 1 Shown, a kind of lyophilized human blood coagulation factor VIII preparation method of the present invention comprises the following steps:

[0098] (1) Collection of plasma and quick-frozen plasma;

[0099] (2) Plasma thawing and separation of cryoprecipitate: pre-thawing the quick-frozen plasma; then thawing the plasma and centrifuging to obtain cryoprecipitate, which is the raw material of human blood coagulation factor VIII;

[0100] (3) cryoprecipitate dissolving: the cryoprecipitate obtained in step (2) is dissolved, and the pH is adjusted;

[0101] (4) Acid precipitation: add acetic acid buffer to the cryoprecipitate lysate in step (3) to adjust the pH and centrifuge to obtain the supernatant;

[0102] (5) Gel adsorption: the supernatant after step (4) was centrifuged, and the pH was adjusted with sodium hydroxide buffer. Then add DEAE SephadexTM A-50 gel for adsorption, after adsorption, filter with a filter element to obtain filtrate A;

[...

Embodiment 1

[0112](1) Plasma collection and quick-freezing: 3.49 tons of fresh human plasma collected was quick-frozen within 30 minutes by flat-plate direct-cooling quick-freezing technology and stored in a -30°C freezer. This batch of plasma passed the virus test and met the quarantine period stipulated by the state.

[0113] (2) Plasma melting and cryoprecipitation: transfer the batch of qualified plasma from the -30°C freezer to the pre-thawing room at 0-4°C for 1 hour, and then spray it with water for injection below 10°C. Alcohol spray disinfection and water for injection rinse alcohol and dry. Break the bag of the raw material plasma and transfer it to the slurry tank, and circulate the water for injection with an interlayer temperature of 30°C to melt the plasma, and perform continuous separation and centrifugation at a speed of 5000-5600 rpm. kg and supernatant.

[0114] (3) Cryoprecipitate dissolving: the 18.0kg cryoprecipitate obtained in step (2) is cut into pieces, and diss...

Embodiment 2

[0137] (1) Plasma collection and quick-freezing: 3.50 tons of fresh human plasma was collected and frozen within 30 minutes by direct-cooling and quick-freezing technology on a plate and stored in a -30°C freezer. This batch of plasma passed the virus test and met the quarantine period stipulated by the state.

[0138] (2) Plasma melting and cryoprecipitation: transfer the batch of qualified plasma from the -30°C cold storage to the pre-thawing room at 0-4°C for 1.5 hours, and then spray it with water for injection below 10°C. Alcohol spray disinfection and water for injection rinse alcohol and dry. Break the bag of the raw material plasma and transfer it to the slurry tank, circulate the water for injection with an interlayer temperature of 30°C to melt the plasma, and perform continuous separation and centrifugation at a speed of 5000-5600 rpm. kg and supernatant.

[0139] (3) Cryoprecipitate dissolution: Cut 18.8kg of cryoprecipitate obtained in step (2) into pieces, diss...

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Abstract

The invention relates to a preparation method of a freeze-dried human blood coagulation factor VIII. The preparation method comprises the following steps of collecting plasma and quick-frozen plasma;performing plasma melting and separating cryoprecipitate; dissolving cryoprecipitate; performing acid precipitation; performing gel adsorption; inactivating S / D virus; performing anion exchange chromatography; performing ultrafiltration; preparing a semi-finished product; carrying out sterilizing and sub-packaging; performing freeze-drying; and carrying out dry heat virus inactivation. The preparation method disclosed by the invention is short in product remelting time, high in specific activity, stable in quality and simple to operate, and after industrialization, the utilization rate of plasma resources can be greatly improved, market supply is increased, and the situation of FVIII medication tension in the Chinese market is relieved.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a preparation method of freeze-dried human blood coagulation factor VIII. Background technique [0002] Diseases caused by the lack of plasma proteins in blood products, such as hemophilia is a blood system disease that causes abnormal bleeding in the body due to the lack of coagulation factors in patients, and endangers internal organs and even life safety. Human blood coagulation factor Ⅷ (FⅧ) is one of the most commonly used blood coagulation factor products in clinical practice. Treatment of surgical bleeding in such patients. Hemophiliacs can live like normal people as long as they get injections of FⅧ, so "human coagulation factor VIII" is vividly called "food" for hemophiliacs. The development of human blood coagulation factor Ⅷ products has transformed the plasma components of many plasma donors into life-saving drugs for hemophiliacs, benefiting many hemophiliacs and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/755C07K1/36C07K1/34C07K1/30C07K1/18C07K1/14
CPCC07K14/755
Inventor 杨莉于引航闫磊郝斌孙婷樊祥彬杨永碧
Owner 哈尔滨派斯菲科生物制药有限公司
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