Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.
CMC
COVID-19, coronavirus
GMP
analytical
anti-viral
chemistry
cleaning
commercial
comparability
control
controls
conventional
distribution
formulation
good manufacturing practice
importation
inspection
manufacturing
packaging
parallel development
presentation
process
regulatory
regulatory authority collaboration
reliance/collaborative assessment
shelf-life
stability
strategy
vaccine
validation
Journal
The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209
Informations de publication
Date de publication:
27 09 2022
27 09 2022
Historique:
received:
15
06
2022
accepted:
02
09
2022
entrez:
28
9
2022
pubmed:
29
9
2022
medline:
30
9
2022
Statut:
epublish
Résumé
This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate 'post-approval' changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.
Identifiants
pubmed: 36168002
doi: 10.1208/s12248-022-00751-9
pii: 10.1208/s12248-022-00751-9
pmc: PMC9514697
doi:
Substances chimiques
Vaccines
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
101Informations de copyright
© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.
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