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The development and certification of the industrial reference standard for identification of meningococcal polysaccharide vaccine group A

Abstract

The article highlights the materials on the development and certification of the industrial reference standard (IRS) for identification of meningococcal polysaccharide vaccine group A. The scheme and methodology for IRS certification have been developed. Samples of the vaccine IRS candidate have been tested in terms of: «Description», «Dissolution time», «Transparency of reconstituted solution «, «Colourity of reconstituted solution», «Particulate matter «, «Loss on drying», «Accuracy of filling» «Phosphorus», «Sterility», «Pyrogenicity», «Abnormal toxicity», confirming their compliance with the current Pharmacopoeia monograph MP-00392-180512. The certified characteristic has been determined: IRS should slow down passive hemagglutination (PHIA) in «A» homologous system with polysaccharide concentration in the range from 0.19 to 0.39 μg per 1 ml in the absence of the inhibitory effect in «C» heterologous system with polysaccharide concentration of 50 μg per 1 ml. The shelf life of the IRS meningococcal group A polysaccharide vaccine for identification has been set against the vaccine shelf life and has been equal to 2 years. The set of regulatory documents on the scientific and technical product IRS 42-28-428-2014 IRS meningococcal group A polysaccharide vaccine for identification (certificate, draft label of primary package and patient information leaflet) has been approved.

About the Authors

M. V. Abramtseva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Leading expert of Laboratory of bacterial vaccines of Test Centre for Quality Expertise of medical immunobiological preparations


T. I. Nemirovskaya
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Laboratory of bacterial vaccines of Test Center for Quality Expertise of medical immunobiological preparations. Candidate of Medical Sciences


O. B. Ustinnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Laboratory of Biochemistry of medical immunobiological preparations of Test Centre for Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences


O. V. Fadeykina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief technologist of Test Centre for Quality Expertise of medical immunobiological preparations. Candidate of Biological 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 of Test Centre for Quality Expertise of medical immunobiological preparations. Doctor of Biological Sciences


A. A. Movsesyants
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Test Center for Quality Expertise of medical immunobiological preparations. Doctor of Medical Sciences, professor


References

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13. ISO Guide 35 Reference Materials. General and statistical principles for certifications. Available from: http://www.iso.org/iso/catalogue_detail.htm?csnumber=39269.


Review

For citations:


Abramtseva M.V., Nemirovskaya T.I., Ustinnikova O.B., Fadeykina O.V., Volkova R.A., Movsesyants A.A. The development and certification of the industrial reference standard for identification of meningococcal polysaccharide vaccine group A. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(4):260-263. (In Russ.)

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ISSN 2221-996X (Print)
ISSN 2619-1156 (Online)