Implementation of the quality-by-design concept for an adeno-associated viral vector-based gene therapy

Implementation of the quality-by-design concept for an adeno-associated viral vector-based gene therapy

INTRODUCTION. Currently, manufacturers of adeno-associated virus (AAV)-based gene therapy products are facing a number of systemic problems stemming from the difficulties in assessing the quality of medicinal products due to insufficient scientific data, limited experience, and imperfect regulatory...

Full description

Saved in:
Bibliographic Details
Main Authors: D. S. Kopein, G. N. Poroshin, R. A. Khamitov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2025-06-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
gene therapy
advanced therapy medicinal product
atmp
adeno-associated virus
aav
adenoassociated viral vector
quality by design
qbd
critical quality attribute
cqa
quality target product profile
qtpp
risk-based approach
aav production technology
duchenne muscular dystrophy
dmd
Online Access:https://www.biopreparations.ru/jour/article/view/580
Tags: Add Tag
No Tags, Be the first to tag this record!

Internet

https://www.biopreparations.ru/jour/article/view/580

Similar Items