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Certification of the branch standard sample of anti-alpha-staphylolysin content, and some aspects of its use

Abstract

The article summarises materials on the certification of a candidate branch standard sample (BSS) of anti-alpha-staphylolysin content - OSO 42-28-342-2017 FSBI «SCEEMP» of the Ministry of Health of Russia, batch No. 34, production date April 1, 2017, expiry date April 1, 2018. According to the Certification programme the reaction of neutralization of staphylococcal toxin hemolytic properties was carried out to establish the range of the certified property of the candidate BSS against the WHO international standard (21±2 IU/ml). The BSS of anti-alpha-staphylolysin content can be used for quantitative determination of antibodies to staphylococcal exotoxin (alpha-staphylolysin) in the reaction of neutralization of staphylococcal toxin (alpha-toxin) hemolytic properties by specific antibodies present in human blood plasma and in a number of biologicals (normal and specific human immunoglobulins, purified and adsorbed staphylococcal toxins, and diagnostic staphylococcal toxin).

About the Authors

E. A. Khusnatdinova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
1st professional category expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences


E. S. Konovalova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
2nd professional category expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality


O. V. Fadeykina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
V. Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. 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 Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences


N. I. Kishkurno
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Senior intellectual property specialist of the Department for Editorial and Publishing Activities and Intellectual Property Protection of the Centre for Planning and Coordination of Scientific Activities


E. Yu. Kudasheva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences


D. V. Shvedov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Deputy head of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences


References

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2. Volkova RA, Fadeikina OV, Klimov VI, Sakanyan EI, Olefir YuV, Merkulov VA et al. Topical issues related to reference standards in the sphere of circulation of biological products. BIOpreparations. Prevention, Diagnosis, Treatment 2016; 16(4): 229–36 (in Russian).

3. Mironov AN, Sakaeva IV, Sakanyan EI, Bunyatyan ND, Kovaleva EL, Mitkina LI et al. Reference standards in international and domestic pharmaceutical analysis. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2012; (3): 56–60 (in Russian).

4. FS. 3.3.1.0005.15. Anatoxin staphylococcal purified adsorbed, suspension for subcutaneous administration. State Pharmacopoeia of the Russian Federation. 13th ed. V. 3. P. 809–16. Available from: http://www.femb.ru/feml (in Russian).

5. FS. 3.3.1.0006.15. Staphylococcal anaphylaxis purified, solution for subcutaneous administration. State Pharmacopoeia of the Russian Federation. 13th ed. V. 3. P. 817–25. Available from: http://www.femb.ru/feml (in Russian).

6. Staphylococcus-alpha antitoxin, equine. Lyophilized, 220 IU. 3rd International Standard. WHO International Biological Reference Preparations. 2017. P. 21. Available from: http://www.who.int/ bloodproducts/ref materials/.

7. OFS. 1.8.2.0008.15. Determination of the content of anti-alpha-staphylolysin (specific antibodies) in medicinal preparations from human and animal blood serum. State Pharmacopoeia of the Russian Federation. 13th ed. V. 2. P. 949–58. Available from: http://www.femb.ru/feml (in Russian).

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9. Scientific and technical products. Realization of strains and industry standard samples of FSBI «SCEEMP» of the Ministry of Health of Russia. Available from: http://www.regmed.ru/content/page/ EXPERTISE_Strains_Purchase (in Russian).

10. Decree of the Chief State Doctor of the Russian Federation of February 17, 2016 ¹ 19 «On the approval of sanitary and epidemiological rules SP 3.3.2.3332-16 Conditions for the transport and storage of immunobiological medicinal products» (in Russian).


Review

For citations:


Khusnatdinova E.A., Konovalova E.S., Fadeykina O.V., Volkova R.A., Kishkurno N.I., Kudasheva E.Yu., Shvedov D.V. Certification of the branch standard sample of anti-alpha-staphylolysin content, and some aspects of its use. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(4):248-252. (In Russ.)

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