Theoretical rationale for the choice of interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping
Abstract
The article provides with the results of theoretical research on justification of the choice of methionine form of recombinant interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping. At present non- methionine and methionine forms of interferon alfa-2b substance are produced in Russia. The reference standard of interferon alfa-2b CRS I0320301, recommended by the European Pharmacopoeia, is a non- methionine standard and is suitable for identification test by peptide mapping only for a non- methionine form of a protein. In order to choose the reference standard candidate for methionine form of interferon alfa-2b, the article provides with the comparative analysis of the range of criteria and methods used by domestic manufacturers to confirm the quality of substances, authorized in the Russian Federation. The theoretical research allowed to choose interferon alfa-2b substance as a reference standard candidate for identification test by peptide mapping.
About the Authors
O. B. Ustinnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Laboratory of Biochemistry of medical immunobiological preparations of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences
Russian Federation
Head of Laboratory of Biochemistry of medical immunobiological preparations of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences
O. B. Runova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Leading expert of Laboratory of Biochemistry of medical immunobiological preparations of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Chemical Sciences
Russian Federation
Leading expert of Laboratory of Biochemistry of medical immunobiological preparations of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Chemical Sciences
E. O. Goloschapova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
2nd professional category expert of Laboratory of Biochemistry of medical immunobiological preparations of Test Center for Quality Expertise of medical immunobiological preparations
Russian Federation
2nd professional category expert of Laboratory of Biochemistry of medical immunobiological preparations of Test Center for Quality Expertise of medical immunobiological preparations
L. V. Korsun
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Department of publishing activity and intellectual property protection of Center of planning and coordination of scientific research. Candidate of Biological Sciences
Russian Federation
Head of Department of publishing activity and intellectual property protection of Center of planning and coordination of scientific research. Candidate of Biological Sciences
References
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Review
For citations:
Ustinnikova O.B., Runova O.B., Goloschapova E.O., Korsun L.V. Theoretical rationale for the choice of interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(3):161-165. (In Russ.)
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