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 ... show 5 more
Citations
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.
