Development and optimization of several stages of the technological process of filgrastim substance production |
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| Authors: | N V Kononova A I Bobruskin T I Kostromina T D Melikhova A A Vainson E V Sveshnikova A A Zinchenko A V Demin V A Martyanov A M Shuster D I Bairamashvili |
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| Institution: | 1. Russian Pharmaceutical Company ZAO Masterklon, Moscow, 127473, Russia
2. Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, Moscow, 117997, Russia
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| Abstract: | Technology of industrial production of an active pharmaceutical substance (APS) of the recombinant human granulocyte colony-stimulating factor (rhG-CSF) involved the use of a highly productive E. coli strain capable of biosynthesis of rhG-CSF in the form of inclusion bodies (IB). A method of strain cultivation has been described, and methods of IB isolation, industrial-scale purification, filgrastim APS production, and quality control have been developed. Clinical trials of the preparation, carried out in the leading Russian clinics, were successful. Efficiency and safety of the preparation have been confirmed. A ready pharmaceutical form Neupomax® been produced in Russia since 2008 according to the technology developed. |
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