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

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.