Development of recombinant adeno-associated virus empty capsids as a reference standard for quality control of gene therapy products

Development of recombinant adeno-associated virus empty capsids as a reference standard for quality control of gene therapy products

INTRODUCTION. The development of adeno-associated virus (AAV)-based gene therapy products in Russia requires establishing reference standards, which are used throughout the pharmaceutical development cycle, and monitoring their stability during the storage period. A preparation of empty capsids of A...

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Main Authors: A. V. Tumaev, D. Yu. Voloshin, E. S. Berdinskikh, E. L. Sakhibgaraeva, E. V. Golovin, E. N. Subcheva, O. O. Vasileva, A. A. Galieva, A. A. Chuvashov, E. S. Novikova, A. V. Karabelsky
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2024-07-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
adeno-associated virus
aav
empty capsid
gene therapy
gene therapy product
pharmaceutical development
quality control methods
reference standard
hek293
affinity chromatography
physical capsid titre
reference standard stability
Online Access:https://www.biopreparations.ru/jour/article/view/549
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