Production method of fibrinogen

A fibrinogen and production method technology, applied in the field of biopharmaceuticals, can solve problems such as the influence of reconstitution time, expensive medicines, and reduced coagulation activity, and achieve good appearance and stability, good coagulation activity, and short reconstitution time Effect

CN111518197APending Publication Date: 2020-08-11哈尔滨派斯菲科生物制药有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2020-08-11

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Abstract

The invention relates to a production method of fibrinogen. The production method comprises the following steps of collecting plasma and quickly freezing plasma; melting plasma and removing cryoprecipitate; preparing a component I precipitate; dissolving the component I precipitate; inactivating virus by adopting an S / D virus inactivation method; performing ethanol precipitation for the first time, and performing centrifuging and dissolving; performing ethanol precipitation for the second time, performing centrifuging and separating a precipitate; preparing a semi-finished product; performingsterilizing and sub-packaging; performing freeze drying; and carrying out dry heat inactivation of viruses. The method has the advantages that the purity of the obtained fibrinogen is greatly improvedand can reach 92% or above; the solidification activity is high and is 18-22 seconds; the re-melting time is short and is 5-10 minutes; after freeze-drying, the appearance is more uniform and stable,the yield is more than 2000 bottles per ton of plasma, and the yield is obviously improved; the long-term stability of the product is good, and the good inherent quality can still be guaranteed after36-month long-term stability test; and due to double virus inactivation, the clinical medication is safer, and no adverse reaction is caused.
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Description

technical field

[0001] The invention belongs to the field of biopharmaceuticals, in particular to a method for producing fibrinogen. Background technique

[0002] Human fibrinogen (fibrinogen, Fg) is coagulation factor I, which is the coagulation factor with the highest content in plasma, and is also a "central" protein in the coagulation system. The final stage of coagulation is the formation of thrombin, which converts fibrinogen to fibrin. In addition to directly participating in the coagulation process, fibrinogen can also mediate platelet aggregation and affect blood viscosity. It is an important risk factor for cardiovascular and cerebrovascular diseases. It also plays an important role in pathological processes such as the formation of atherosclerosis and tumor metastasis. Fg gene defects can lead to congenital hypofibrinogenemia (or no) and dysfibrinogenemia.

[0003] Fibrinogen directly participates in the coagulation process mainly as coagulation factor I. In t...

Examples

Embodiment 1

[0107] (1) Plasma collection and quick-freezing: 3.48 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.

[0108](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 melting 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 5,000-5,600 rpm. The liquid intake of the centrifuge is 900 L / min. kg and the supernatant, and stored in a -30°C freezer.

[0109] (3) Preparation o...

Embodiment 2

[0122] (1) Plasma collection and quick-freezing: 3.51 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.

[0123] (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 melting 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 the supernatant, and stored in a -30°C freezer.

[0124] (3) Preparation of Component I Precipitation: Transfer the supe...

Embodiment 3

[0137] (1) Plasma collection and quick-freezing: 3.45 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.

[0138] (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 2 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, 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 the supernatant, and stored in a -30°C freezer.

[0139] (3) Preparation of Component I Precipitation: Transfer the supernatant ...