METHOD FOR CRYOPRESERVATION OF INTERMEDIATE PRODUCT OF BLOOD COAGULATION FACTOR VIII Russian patent published in 2024 - IPC A61K38/37 C07K1/16 C07K1/34 

FIELD: medicine.

SUBSTANCE: group of inventions relates to a method for cryopreservation of an intermediate product of blood coagulation factor VIII, technological process of preparing a blood coagulation factor VIII preparation, a method for reducing deposition of impurities in a blood coagulation factor VIII product, method of improving long-term stability of blood coagulation factor VIII product. Method for cryopreservation of an intermediate product of blood coagulation factor VIII comprises: cryopreservation, as an intermediate product of blood coagulation factor VIII, any of the concentrated blood coagulation factor VIII solution or the blood coagulation factor VIII chromatographic eluent before preparing the mother solution, or before concentration by ultrafiltration, or after concentration by ultrafiltration during preparation of factor VIII, and combinations or versions thereof, wherein: freezing rate of the intermediate blood coagulation factor VIII product is in range from 1 °C/min to 10 °C/min, blood coagulation factor VIII intermediate product is stored at temperatures from 15 °C to 196 °C, and the blood coagulation factor VIII intermediate product has pH of 6.5 to 7.2. Technological process for preparing a blood coagulation factor VIII preparation containing a method for cryopreservation of an intermediate product of blood coagulation factor VIII. Method for reducing deposition of impurities in a blood coagulation factor VIII product, comprising: cryopreservation, within the process of obtaining a blood coagulation factor VIII product, an intermediate product of blood coagulation factor VIII using the above cryopreservation method. Method of improving long-term stability of blood coagulation factor VIII product, comprising: cryopreservation, within the technological process of obtaining a blood coagulation factor VIII product, an intermediate product of blood coagulation factor VIII using a cryopreservation method.

EFFECT: group of inventions described above enables cryopreservation of an intermediate product of blood coagulation factor VIII with increased long-term stability.

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