Quality by Design for enabling RNA platform production processes.

Quality Control RNA / genetics Technology, Pharmaceutical
Quality by Design RNA lipid nanoparticle process modeling

Journal

Trends in biotechnology
ISSN: 1879-3096
Titre abrégé: Trends Biotechnol
Pays: England
ID NLM: 8310903

Informations de publication

Date de publication:
10 2022
Historique:
received: 02 12 2021
revised: 18 03 2022
accepted: 28 03 2022
pubmed: 2 5 2022
medline: 20 9 2022
entrez: 1 5 2022
Statut: ppublish

Résumé

RNA-based products have emerged as one of the most promising and strategic technologies for global vaccination, infectious disease control, and future therapy development. The assessment of critical quality attributes (CQAs), product-process interactions, relevant process analytical technologies, and process modeling capabilities can feed into a robust Quality by Design (QbD) framework for future development, design, and control of manufacturing processes. QbD implementation will help the RNA technology reach its full potential and will be central to the development, pre-qualification, and regulatory approval of rapid response, disease-agnostic RNA platform production processes.

Identifiants

DOI: 10.1016/j.tibtech.2022.03.012 PMID: 35491266
pubmed: 35491266
pii: S0167-7799(22)00080-4
doi: 10.1016/j.tibtech.2022.03.012
pii:
doi:

Substances chimiques

RNA 63231-63-0

Types de publication

Journal Article Review Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1213-1228

Subventions

Organisme : Department of Health
Pays : United Kingdom

Informations de copyright

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests The authors have no interests to declare.

Auteurs

Simon Daniel (S)

Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK.

Zoltán Kis (Z)

Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK; Department of Chemical and Biological Engineering, The University of Sheffield, Sheffield, UK. Electronic address: z.kis@sheffield.ac.uk.

Cleo Kontoravdi (C)

Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK.

Nilay Shah (N)

Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK. Electronic address: n.shah@imperial.ac.uk.

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Classifications MeSH

questionsmedicales.fr › Technologie, industrie et agriculture › Technologie › Contrôle de qualité › Quality by Design for enabling RNA platform...
questionsmedicales.fr › Acides nucléiques, nucléotides et nucléosides › Acides nucléiques › ARN › Quality by Design for enabling RNA platform...
questionsmedicales.fr › Technologie, industrie et agriculture › Technologie › Technologie pharmaceutique › Quality by Design for enabling RNA platform...