Mass spectrometry methods for standardization of allergenic preparations
Abstract
The present article highlights the issues of standardization of diagnostic and therapeutic allergen extracts used for allergen-specific immunotherapy (ASIT) in Russia and abroad. Quality evaluation methods for finished immunobiologicals (allergens) in accordance with the regulatory documents and using biological, immunochemical and advanced physical and chemical analytical techniques (in vitro and in vivo diagnosis) have been considered. Basic standardization strategies for allergenic preparations (determination of total allergenic activity, biological activity, the content of major allergens) have been presented. Two systems of allergen standardization (allergen units and biological units) have been introduced. The potential for use of high-performance liquid chromatography combined with mass spectrometry (HPLC-MS) as the most promising method for the standardization of allergen extracts has been considered. The advantages and disadvantages of the mentioned method for the standardization of allergens has been described. The method of chromatographic analysis of the total extract of drooping birch pollen, developed by the experts of the Chair of Pharmaceutical and Toxicological Chemistry of the I. M. Sechenov First Moscow State Medical University, has been given as an example.
About the Authors
V. V. Smirnov
I. M. Sechenov First Moscow State Medical University
Russian Federation
Docent of the Department of pharmaceutical and toxicological chemistry. Candidate of Pharmaceutical Sciences
Russian Federation
Docent of the Department of pharmaceutical and toxicological chemistry. Candidate of Pharmaceutical Sciences
A. A. Ignatov
I. M. Sechenov First Moscow State Medical University
Russian Federation
Post-graduate student of the Department of pharmaceutical and toxicological chemistry
Russian Federation
Post-graduate student of the Department of pharmaceutical and toxicological chemistry
V. N. Kuzina
I. M. Sechenov First Moscow State Medical University
Russian Federation
Docent of the Department of pharmaceutical and toxicological chemistry. Candidate of Pharmaceutical Sciences
Russian Federation
Docent of the Department of pharmaceutical and toxicological chemistry. Candidate of Pharmaceutical Sciences
S. P. Dementiev
I. M. Sechenov First Moscow State Medical University
Russian Federation
Docent of the Department of pharmaceutical and toxicological chemistry. Candidate of Pharmaceutical Sciences
Russian Federation
Docent of the Department of pharmaceutical and toxicological chemistry. Candidate of Pharmaceutical Sciences
G. V. Ramenskaya
I. M. Sechenov First Moscow State Medical University
Russian Federation
Head of the Department of pharmaceutical and toxicological chemistry. Doctor of Pharmaceutical Sciences, professor
Russian Federation
Head of the Department of pharmaceutical and toxicological chemistry. Doctor of Pharmaceutical Sciences, professor
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Review
For citations:
Smirnov V.V., Ignatov A.A., Kuzina V.N., Dementiev S.P., Ramenskaya G.V. Mass spectrometry methods for standardization of allergenic preparations. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(3):166-171. (In Russ.)
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