Method for liquid preservation of intermediate product of human prothrombin complex

Abstract

The invention relates to a method for liquid preservation of an intermediate product of a human prothrombin complex. The method comprises the following steps: (1) carrying out plasma adsorption, namely stirring and adsorbing plasma of which cryoprecipitate is removed by using balanced gel; (2) washing the gel, and removing protein components in a non-human prothrombin complex; (3) eluting the gel,and collecting an elution liquid, namely eluting the gel washed in the step (2) by using an elution liquid, and collecting the elution liquid; (4) carrying out ultrafiltration on the elution liquid;(5) preserving an intermediate product, namely sealing and preserving a concentrated liquid at a non-frozen state of the intermediate product; (6) carrying out detection. By adopting the method, the intermediate product of the human prothrombin complex is preserved, and good activity of the intermediate product can be maintained; control on the production process is facilitated, and the risks of instability and contamination of a product at switched solid and liquid states can be reduced; cryopreservation and remelting processes are avoided, and the production efficiency can be improved.

Description

technical field [0001] The invention belongs to the field of biopharmaceutical blood product production, and in particular relates to a method for liquid preservation of an intermediate product of human prothrombin complex. Background technique [0002] Human coagulation factor IX (Factor IX, FIX) is a vitamin K-dependent plasma protein synthesized by the liver, with a molecular weight of about 57KD and a plasma content of 1-7 mg / L. It is an important factor in the intrinsic coagulation pathway. FIX has similar physical and chemical properties to other vitamin K-dependent blood coagulation factors Ⅱ, Ⅶ, and Ⅹ, and forms the human prothrombin complex (Prothrombin Complex Concetrate, PCC) together with the above three factors. [0003] At present, the main production process of PCC is two-step gel adsorption: use the plasma or Cohn component III from which cryoprecipitation has been removed as raw material, and collect the eluate after being adsorbed by DEAE Sephadex A-50; Or...

AI Technical Summary

Problems solved by technology

The production process of PCC is relatively complicated, and the production cycle is relatively long. The intermediate product is often frozen and stored after the first gel adsorption, and the frozen product is rethawed in the next step.

However, due to the characteristics of coagulation factors that are easily activated and unstable, the rethawing of the intermediate product components after freezing will cause the loss of coagulation factor activity. At the same time, there is a risk of microbial contamination of the intermediate products during storage, which also brings inconvenience to the operation.