Nair, A. orcid.org/0000-0002-2592-116X, Loveday, K.A., Kenyon, C. et al. (2 more authors) (2024) Quality by Digital Design for Developing Platform RNA Vaccine and Therapeutic Manufacturing Processes. In: Kramps, T., (ed.) RNA Vaccines: Methods and Protocols. Methods in Molecular Biology, 2786 . Humana New York, NY , pp. 339-364.
Abstract
Quality by digital design (QbDD) utilizes data-driven, mechanistic, or hybrid models to define and optimize a manufacturing design space. It improves upon the QbD approach used extensively in the pharmaceutical industry. The computational models developed in this approach identify and quantify the relationship between the product’s critical quality attributes (CQAs) and the critical process parameters (CPPs) of unit operations within the manufacturing process. This chapter discusses the QbDD approach in developing and optimizing unit operations such as in vitro transcription, tangential flow filtration, affinity chromatography, and lipid nanoparticle (LNP) formulation in mRNA vaccine manufacturing. QbDD can be an efficient framework for developing a production process for a disease-agnostic product that requires extensive experimental and model-based process-product interaction characterization during the early process development phase.
Metadata
Item Type: | Book Section |
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Authors/Creators: |
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Editors: |
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Copyright, Publisher and Additional Information: | © 2024 The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature. |
Keywords: | Affinity chromatography; Digital twins; In vitro transcription; Lipid nanoparticle; Quality by digital design; Tangential flow filtration; mRNA vaccines; Humans; Quality Control; Nanoparticles; mRNA Vaccines; Lipids; Chromatography, Affinity; Liposomes |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Engineering (Sheffield) > School of Chemical, Materials and Biological Engineering The University of Sheffield > Faculty of Engineering (Sheffield) > Department of Chemical and Biological Engineering (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 20 Dec 2024 12:10 |
Last Modified: | 20 Dec 2024 12:10 |
Status: | Published |
Publisher: | Humana New York, NY |
Series Name: | Methods in Molecular Biology |
Refereed: | Yes |
Identification Number: | 10.1007/978-1-0716-3770-8_16 |
Related URLs: | |
Sustainable Development Goals: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:220662 |