Development and certification of an industrial reference standard for determination of filgrastim activity
Abstract
The article provides with the information on certification of an industrial reference standard (IRS) for determination of filgrastim activity. In order to confirm the quality of the IRS candidate, the following tests have been performed: biological activity, description, identification, clarity, colority, sterility, pH, foreign impurities, bacterial endotoxins, as well as the assay of: Filgrastim, Acetate ion, Polysorbate 80, residual Host Cell Proteins, residual Host Cell DNA. The results fully meet the requirements for filgrastim samples. The reference standard is certified for biological activity. The purpose of the IRS for determination of filgrastim activity is the assessment of acceptability of the results of biological activity tests in the quality control of substances and drugs based on filgrastim. Biological activity of the IRS candidate has been assessed by interlaboratory studies as compared against the second international standard NIBSC-09/136. The certified value for «Biological activity» of the IRS for determination of filgrastim activity has been set as 32.2±5.35 million IU/ml. The shelf-life under the storage conditions of 2 to 8oC has been set as not less than 2 years. The results of long-term stability studies the IRS confirm its stability during the monitored period.
About the Authors
E. V. Motuzova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations. Candidate of Biological Sciences
Russian Federation
Chief expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations. Candidate of Biological Sciences
N. A. Alpatova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of Laboratory of immunology of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences
Russian Federation
Chief expert of Laboratory of immunology of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences
L. A. Gayderova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Laboratory of immunology of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Medical Sciences
Russian Federation
Head of Laboratory of immunology of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Medical Sciences
O. B. Runova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief 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
Chief expert of Laboratory of Biochemistry of medical immunobiological preparations of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Chemical Sciences
R. A. Volkova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of molecular biology and genetic testing methods. Doctor of Biological Sciences
Russian Federation
Head of the Laboratory of molecular biology and genetic testing methods. Doctor of Biological Sciences
E. D. Mytsa
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
2nd professional category expert of the Laboratory of molecular biology and genetic testing methods
Russian Federation
2nd professional category expert of the Laboratory of molecular biology and genetic testing methods
V. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Director of Center for Examination and Control of medical immunobiological preparations. Doctor of Medical Sciences, professor
Russian Federation
Director of Center for Examination and Control of medical immunobiological preparations. Doctor of Medical Sciences, professor
A. A. Wainson
NN Blokhin Russian Cancer Research Center
Russian Federation
Leading researcher of the Laboratory of Experimental Radiobiology of the Department of Experimental Radiology of the Institute of Clinical and Experimental Radiology. Doctor of Biological Sciences, professor
Russian Federation
Leading researcher of the Laboratory of Experimental Radiobiology of the Department of Experimental Radiology of the Institute of Clinical and Experimental Radiology. Doctor of Biological Sciences, professor
V. V. Mesherikova
NN Blokhin Russian Cancer Research Center
Russian Federation
Leading researcher of the Laboratory of Experimental Radiobiology of the Department of Experimental Radiology of the Institute of Clinical and Experimental Radiology. Candidate of Biological Sciences
Russian Federation
Leading researcher of the Laboratory of Experimental Radiobiology of the Department of Experimental Radiology of the Institute of Clinical and Experimental Radiology. Candidate of Biological Sciences
R. A. Khamitov
International Biotechnology Center «Generium»
Russian Federation
Director-General. Doctor of Medical Sciences, professor
Russian Federation
Director-General. Doctor of Medical Sciences, professor
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Review
For citations:
Motuzova E.V., Alpatova N.A., Gayderova L.A., Runova O.B., Volkova R.A., Mytsa E.D., Bondarev V.P., Wainson A.A., Mesherikova V.V., Khamitov R.A. Development and certification of an industrial reference standard for determination of filgrastim activity. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(3):172-178. (In Russ.)
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