Review of methodological approaches to quality evaluation of recombinant interferon products
Abstract
The article summarises methods used to control the quality of recombinant interferon alpha and beta (IFNs) products. It demonstrates that currently used methodological approaches generally ensure proper quality control of this group of medicines. However, it is necessary to formulate basic requirements for the pharmacopoeial general chapters on interferon alpha-2 and beta-1 products in order to standardize the control procedures and increase the efficacy and safety of recombinant IFNs products. These requirements should be harmonized with requirements of both the European Pharmacopeia and pharmacopoeias of the Eurasian Economic Union member-states, and should take account of the current trends in the Russian pharmaceutical industry.
About the Authors
O. B. Ustinnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of MIBPs Biochemistry of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Russian Federation
Head of the Laboratory of MIBPs Biochemistry of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
L. A. Gayderova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
Russian Federation
Head of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
M. L. Baykova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
2nd professional category expert of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
Russian Federation
2nd professional category expert of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
T. N. Lobanova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Leading expert of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Russian Federation
Leading expert of the Immunology Laboratory of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
I. M. Shcherbachenko
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Leading expert of the Laboratory of MIBPs Biochemistry of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Russian Federation
Leading expert of the Laboratory of MIBPs Biochemistry of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
E. O. Goloshchapova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
2nd professional category expert of the Laboratory of MIBPs Biochemistry of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
Russian Federation
2nd professional category expert of the Laboratory of MIBPs Biochemistry of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
V. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences
Russian Federation
Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences
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Review
For citations:
Ustinnikova O.B., Gayderova L.A., Baykova M.L., Lobanova T.N., Shcherbachenko I.M., Goloshchapova E.O., Bondarev V.P. Review of methodological approaches to quality evaluation of recombinant interferon products. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(3):152-157. (In Russ.)
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