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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. [ABSTRACT FROM AUTHOR]

Chemical, manufacturing, and control development timelines occupy a significant part of vaccine end-to-end development. In the on-going race for accelerating timelines, in silico process development constitutes a viable strategy that can be achieved through an artificial intelligence (AI)-driven or a mechanistically oriented approach. In this opinion, we focus on the mechanistic option and report on the modeling competencies required to achieve it. By inspecting the most frequent vaccine process units, we identify fluid mechanics, thermodynamics and transport phenomena, intracellular modeling, hybrid modeling and data science, and model-based design of experiments as the pillars for vaccine development. In addition, we craft a generic pathway for accommodating the modeling competencies into an in silico process development strategy. The development of mechanistically oriented in silico processes would be useful for vaccines. Fluid mechanics, thermodynamics and transport phenomena, intracellular modeling, hybrid modeling and data science, and model-based design of experiments are pivotal competences for in silico process development. A generic pathway can accommodate these modeling competencies into an in silico process development strategy. [ABSTRACT FROM AUTHOR]