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
References
1. Federal law «On Ratification of the Agreement on Uniform Principles and Rules for the Treatment of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union» ¹ 4-FZ of January 31, 2016 (in Russian).
2. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological / Biological Products. International Conference on Harmonisation. 1999. https://goo.gl/CYCLvi.
3. Volkova RA, Avdeeva ZhI, El’bert EV, Alpatova NA, Borisevich IV. The requirements to characteristics of expressing structure and refined protein for performing preclinical trials of new immunobiological preparations, derived using gene engineering methods. BIOpreparations. Prevention, Diagnosis, Treatment 2011; 3: 49–52 (in Russian).
4. Olefir YuV, Medunitsyn NV, Avdeeva ZhI, Soldatov AA, Movsesyants AA, Merkulov VA, Bondarev VP. Modern biological/biotechnological medicinal products. Topical issues and prospects for development. BIOpreparations. Prevention, Diagnosis, Treatment 2016; 16 (2): 67–77 (in Russian).
5. Alpatova NA, Gayderova LA, Yakovlev AK, Motuzova EV, Lysikova SL, Soldatov AA, Avdeeva ZhI Assessment of biotechnological products specific activity. BIOpreparations. Prevention, Diagnosis, Treatment. 2017. 17 (1): 13–26 (in Russian).
6. Osterman LA Methods for studying proteins and nucleic acids. Ì.: Nauka; 1981 (in Russian).
7. Interferon alfa-2 concentrated solution. European Pharmacopoeia 9.0. Available from: http://online6.edqm.eu/ep900.
8. Interferon beta-1a concentrated solution. European Pharmacopoeia 9.0. Available from: http://online6.edqm.eu/ep900.
9. MYK 4.1/4.2.588–96 «Methods of monitoring medical immunobiological drugs administered to people » (in Russian).
10. OFS. 1.7.1.0007.15. Medicines obtained by recombinant DNA methods. State Pharmacopoeia of the Russian Federation. 13th ed. 2016. P. 521–41.
11. Betaferon®, 25 Jahre Multiple Sklerose Forschung. Editors: Thomas Berger, Michael Linnebank, Heinz Wiendl. ISBN: 978-3-7091-1765–1 (Print), 978-3-7091-1766-8 (Online).
12. Murdoch D1, Lyseng-Williamson KA. Spotlight on Subcutaneous Recombinant Interferon--1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis. BioDrugs. 2005, 19, (5): 323–325.
13. Mero A, Clementi C, Veronese FM, Pasut G. Covalent conjugation of poly(ethylene glycol) to proteins and peptides: strategies and methods. Methods Mol Biol. 2011. 751:95–129.
14. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CÐMP/BWP/3068/03). European Medicines Agency. Available from: https://goo.gl/GUC2Le.
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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