A 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 human prothrombin complex. The steps are: (1) plasma adsorption, using a balanced gel to stir and absorb the plasma from which cryoprecipitation has been removed; (2) gel washing, washing Gel, remove the protein components in the non-human prothrombin complex; (3) Gel elution, collect the eluate, use the eluent to elute the gel after washing in step (2), and collect the eluate ; (4) Ultrafiltration of the eluent; (5) Preservation of the intermediate product, sealing and storing the concentrated solution in a non-frozen state of the intermediate product; (6) Detection. Preserving the intermediate product of human prothrombin complex under the conditions of the present invention enables the intermediate product to better maintain its activity; it is beneficial to the control of the production process and reduces the risk of instability and contamination of the product under the conversion of different solid-liquid states; no need The process of freezing and rethawing is conducive to improving production efficiency.

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.