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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
Niebel, Bastian
Natalis, Laurent
Meln, Irina
Perea-Vélez, Mónica
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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 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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2024-12-31
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