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Accelerating vaccine manufacturing development through model-based approaches : current advances and future opportunities

Ramin, Elham ; Cardillo, Antonio Gaetano ; Liebers, Reinhard ; Schmölder, Johannes ; von Lieres, Eric ; Van Molle, Wim ; Niebel, Bastian ; Natalis, Laurent ; Meln, Irina and Perea-Vélez, Mónica , et al. (2024) In Current Opinion in Chemical Engineering 43.
Abstract

This review highlights the importance of model-based approaches in accelerating vaccine manufacturing process development. The challenges of scaling up from laboratory to commercial processes are addressed through the adoption of Process Analytical Technology frameworks and Quality by Design principles. The application of various modeling approaches beyond downstream and upstream processes in vaccine production is discussed in detail. These in silico process simulation approaches enable deeper understanding of manufacturing dynamics, identification of critical process parameters, and the development of well-defined design spaces, ultimately leading to accelerated vaccine development and improved product quality. The authors stress the... (More)

This review highlights the importance of model-based approaches in accelerating vaccine manufacturing process development. The challenges of scaling up from laboratory to commercial processes are addressed through the adoption of Process Analytical Technology frameworks and Quality by Design principles. The application of various modeling approaches beyond downstream and upstream processes in vaccine production is discussed in detail. These in silico process simulation approaches enable deeper understanding of manufacturing dynamics, identification of critical process parameters, and the development of well-defined design spaces, ultimately leading to accelerated vaccine development and improved product quality. The authors stress the significance of an integrated modeling platform for vaccine manufacturing, exemplified by the Inno4Vac project. This initiative seeks to develop a comprehensive computational platform for vaccine manufacturing and stability testing, with a particular focus on stakeholder engagement and collaboration with regulatory bodies to ensure the acceptance and implementation of the platform.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Current Opinion in Chemical Engineering
volume
43
article number
100998
publisher
Elsevier
external identifiers
  • scopus:85181018886
ISSN
2211-3398
DOI
10.1016/j.coche.2023.100998
language
English
LU publication?
yes
id
0db5dfc6-bea5-40ed-9962-98b67b842ccf
date added to LUP
2024-02-12 11:43:57
date last changed
2024-02-13 08:32:13
@article{0db5dfc6-bea5-40ed-9962-98b67b842ccf,
  abstract     = {{<p>This review highlights the importance of model-based approaches in accelerating vaccine manufacturing process development. The challenges of scaling up from laboratory to commercial processes are addressed through the adoption of Process Analytical Technology frameworks and Quality by Design principles. The application of various modeling approaches beyond downstream and upstream processes in vaccine production is discussed in detail. These in silico process simulation approaches enable deeper understanding of manufacturing dynamics, identification of critical process parameters, and the development of well-defined design spaces, ultimately leading to accelerated vaccine development and improved product quality. The authors stress the significance of an integrated modeling platform for vaccine manufacturing, exemplified by the Inno4Vac project. This initiative seeks to develop a comprehensive computational platform for vaccine manufacturing and stability testing, with a particular focus on stakeholder engagement and collaboration with regulatory bodies to ensure the acceptance and implementation of the platform.</p>}},
  author       = {{Ramin, Elham and Cardillo, Antonio Gaetano and Liebers, Reinhard and Schmölder, Johannes and von Lieres, Eric and Van Molle, Wim and Niebel, Bastian and Natalis, Laurent and Meln, Irina and Perea-Vélez, Mónica and Clénet, Didier and Jørgensen, John Bagterp and Nilsson, Bernt and Bracewell, Daniel G. and Gernaey, Krist V.}},
  issn         = {{2211-3398}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{Current Opinion in Chemical Engineering}},
  title        = {{Accelerating vaccine manufacturing development through model-based approaches : current advances and future opportunities}},
  url          = {{http://dx.doi.org/10.1016/j.coche.2023.100998}},
  doi          = {{10.1016/j.coche.2023.100998}},
  volume       = {{43}},
  year         = {{2024}},
}