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Kononova N.V.,Russian Pharmaceutical Company ZAO Masterklon | Bobruskin A.I.,Russian Pharmaceutical Company ZAO Masterklon | Kostromina T.I.,RAS Shemyakin Ovchinnikov Institute of Bioorganic Chemistry | Melikhova T.D.,RAS Shemyakin Ovchinnikov Institute of Bioorganic Chemistry | And 7 more authors.
Applied Biochemistry and Microbiology | Year: 2010

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. © 2010 Pleiades Publishing, Ltd. Source


Kononova N.V.,Russian Pharmaceutical Company ZAO Masterklon | Yakovlev A.V.,Russian Pharmaceutical Company ZAO Masterklon | Zhuravko A.M.,Russian Pharmaceutical Company ZAO Masterklon | Pankeev N.N.,Russian Pharmaceutical Company ZAO Masterklon | And 3 more authors.
Russian Journal of Bioorganic Chemistry | Year: 2014

A unified technology platform for the production of two medical products with nonprolonged and prolonged action on the basis of the recombinant human granulocyte colony-stimulating factor (filgrastim) was developed. The production cost for the previously developed domestic medical product was reduced by the unified technology. Moreover, the introduction of an additional step for the PEGylation of the recombinant granulocyte colony stimulating factor to the technological line allowed the start of the production of a new generation of the medical product and standardization of the documenting procedure for the technological process in accordance with GMP requirements. © 2014 Pleiades Publishing, Ltd. Source

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