New approaches to quality control of new generation recombinant vaccines

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Abstract

Introduction. The work is devoted to the development and presentation of an approach to determine the concentration of a new generation immunobiological preparation (VLP vaccine) by an innovative method based on diffuse scattering in optically turbid media. Since the development of new vaccines is highly dependent on the availability of analytical methods for their design and evaluation, hence, the relevance of the study stems from the need to introduce non-destructive and rapid methods of analysis into medicine.
The aim of the work is to develop a new analytical solution for quantitative determination of a new generation VLP vaccine based on diffuse light reflection in an optically inhomogeneous medium.

Material and Methods. The object of the study was a sample of vaccine based on virus-like particles for the prevention of rotavirus infection - oil-in-water emulsion for intramuscular administration; 1 vial - 1 dose (160 µg, 0.5 ml/dose) with nanoemulsified squalene adjuvant (Sepivac SWE). Bovine serum albumin - lyophilised powder 98% (BIOLITE, St. Petersburg) acted as a model protein object. The electronic spectra were obtained using an Agilent Cary 60 spectrophotometer; particle size distribution from 0.1 nm to 10000 nm was determined on a ZetasizerNano ZS dynamic light scattering (DLS) spectrometer (MALVERN Instruments, Malvern, UK). To determine vaccine concentration, an innovative approach based on diffuse photoexcitation of secondary waves from light scattering centres in the tested protein preparations followed by chemometric processing of kinetics of diffuse reflection patterns was used.

Results. On the basis of the constructed calibration straight line and the value of the sd2 descriptor, which demonstrated the stability of values within the framework of intra-laboratory reproducibility of the test sample, the concentration of Gam-VLP-rot vaccine (160 μg/dose) in the test solution (in terms of 1 ml) was determined.

Conclusions. The obtained results will find application in the field of pharmaceutical chemistry, immunobiology, biomedicine at the stage of development and quality control of vaccines, immune sera and globulins as an accessible, express and reliable method of quantification.

About the authors

Ainaz Safdari

Peoples' Friendship University of Russia named after Patrice Lumumba (RUDN University)

Author for correspondence.
Email: ainazsafdari98@gmail.com
ORCID iD: 0009-0004-5238-5042
SPIN-code: 2905-7221

Post-graduate Student, Department of Pharmaceutical and Toxicological Chemistry

Russian Federation, 8 Miklukho-Maklaya str., Moscow, 117198

E. V. Uspenskaya

Peoples' Friendship University of Russia named after Patrice Lumumba (RUDN University)

Email: uspenskaya75@mail.ru
ORCID iD: 0000-0003-2147-8348
SPIN-code: 6729-8280

Dr.Sc. (Pharm.), Associate Professor, Professor of the Department of Pharmaceutical and Toxicological Chemistry

Russian Federation, 8 Miklukho-Maklaya str., Moscow, 117198

A. V. Syroeshkin

Peoples' Friendship University of Russia named after Patrice Lumumba (RUDN University)

Email: syroeshkin_av@pfur.ru
ORCID iD: 0000-0003-3279-7520
SPIN-code: 5409-8980

Dr.Sc. (Biol.), Professor, Head of Department of Pharmaceutical and Toxicological Chemistry

Russian Federation, 8 Miklukho-Maklaya str., Moscow, 117198

T. V. Grebennikova

The Federal Government Budgetary Institution “National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation”

Email: t_grebennikova@mail.ru
ORCID iD: 0000-0002-6141-9361
SPIN-code: 9437-9589

Dr.Sc. (Biol.), Professor, Corresponding Member of RAS

Russian Federation, 18 Gamaleya str., Moscow, 123098

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