Quality by design for enabling RNA platform production processes
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Published version
Author(s)
Daniel, Simon
Kis, zoltan
Kontoravdi, Kleio
Shah, nilay
Type
Journal Article
Abstract
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, 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. Its implementation will help the RNA technology to reach its full potential and will be central in the development, pre-qualification and regulatory approval of rapid response, disease-agnostic RNA platform production processes.
Date Issued
2022-10
Date Acceptance
2022-03-28
Citation
Trends in Biotechnology, 2022, 40 (10), pp.1213-1228
ISSN
0167-7799
Publisher
Cell Press
Start Page
1213
End Page
1228
Journal / Book Title
Trends in Biotechnology
Volume
40
Issue
10
Copyright Statement
© 2022 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
License URL
Sponsor
Engineering & Physical Science Research Council (EPSRC)
Engineering & Physical Science Research Council (EPSRC)
Identifier
https://www.sciencedirect.com/science/article/pii/S0167779922000804?via%3Dihub
Grant Number
EP/R013764/1
EP/V01479X/1
Subjects
Quality by Design
RNA
lipid nanoparticle
process modeling
Quality Control
RNA
Technology, Pharmaceutical
RNA
Technology, Pharmaceutical
Quality Control
Biotechnology
06 Biological Sciences
09 Engineering
10 Technology
Publication Status
Published
Date Publish Online
2022-04-29