RECOMBINANT BLOOD COAGULATION FACTORS: STRUCTURE FEATURES AND QUALITY ASSESSMENT

DOI: https://doi.org/None

O.B. Ustinnikova, V.P. Bondarev, O.B. Rounova, E.V. Novikova, E.V. Gorbunova Scientific Center on Expertise of Medical Application Products, Petrovskiy boulevard, 8, Moscow, 127051, Russian Federation

The review is devoted to problems of quality assessment of recombinant coagulation factors approved in the Russian Federation. The list of recombinant blood coagulation factor products approved in the world was provided. Benefits of the use of recombinant blood coagulation factor products in comparison with plasma-derived products were reflected. The adverse effect of the use of plasma-derived therapeutic products, namely the induction of inhibitors, was detected. There are considered structure features and post translational modifications of recombinant factors VII, VIII, IX with specification to its international nonproprietary names. Aspects of the international practice in potency evaluation, identification, purity of the recombinant coagulation factors were described. International reference standards, used for the evaluation of potency and physicochemical properties were mentioned. There is an existing problem of the quality assessment of recombinant coagulation factor VIII due to the lack of international and industrial reference standards for the evaluation of physicochemical properties, as well as because of the fact, that in European Pharmacopoeia there are only two monographs for modifications of recombinant coagulation factor VIII (octocog alfa and beroctocog alfa) out of five approved ones in the World. It is mentioned that Russian Pharmacopoeia does not include requirements for the recombinant blood coagulation factors and perspective approaches to the composing of the national regulatory system for the quality assessment of these products were considered.
Keywords: 
recombinant blood coagulation factors, reference standards, quality assessment, post-translational modifications
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