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.

本综述强调了基于模型的方法在加速疫苗生产工艺开发方面的重要性。通过采用工艺分析技术框架和质量源于设计原则，解决了从实验室工艺扩展到商业工艺的挑战。详细讨论了疫苗生产中下游和上游流程之外的各种建模方法的应用。这些计算机过程模拟方法可以更深入地了解制造动态、识别关键过程参数以及开发明确的设计空间，最终加速疫苗开发并提高产品质量。作者强调了疫苗制造集成建模平台的重要性，以 Inno4Vac 项目为例。该计划旨在开发一个用于疫苗制造和稳定性测试的综合计算平台，特别注重利益相关者的参与以及与监管机构的合作，以确保该平台的接受和实施。