Methodological Approaches to Validation of Therapeutic Recombinant Proteins Production Based on the Quality by Design Concept

Validation of production processes based on the Quality by Design (QbD) principles calls for thorough scientific understanding of the processes and enhancement of their stability by implementation of new technologies. The aim of the study consisted in substantiating a QbD-based technological approac...

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Bibliographic Details
Main Authors: N. V. Stratonova, A. S. Lisov, A. N. Morozov, D. V. Tyupa, R. A. Khamitov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-09-01
Series:Биопрепараты: Профилактика, диагностика, лечение
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Online Access:https://www.biopreparations.ru/jour/article/view/173
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