Accelerating vaccine manufacturing development through model-based approaches: current advances and future opportunities
Elham Ramin, Antonio Gaetano Cardillo, Reinhard Liebers, Johannes Schmölder, Eric von Lieres, Wim Van Molle, Bastian Niebel, Laurent Natalis, Irina Meln, Mónica Perea-Vélez, Didier Clénet, John Bagterp Jørgensen, Bernt Nilsson, Daniel G. Bracewell, Krist V. Gernaey
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.