New paper examines regulatory perspectives on in silico tools for vaccine biomanufacturing

The paper presents key outcomes from a stakeholder workshop that convened experts from academia, industry, and regulatory authorities across the EU, Canada, and the US.

April 2025

Inno4Vac partners have published a new article in Vaccine titled “Advancing regulatory dialogue: In silico models for improved vaccine biomanufacturing - an expert meeting report.” The aim was to discuss on how in silico models, used to simulate and optimise vaccine manufacturing processes, can be aligned with regulatory expectations and incorporated into existing regulatory frameworks.

Key discussion points included current regulatory expectations, opportunities for harmonisation, and the importance of early and transparent dialogue between developers and regulatory bodies as well as the potential of digital tools to streamline vaccine development. The article outlines practical recommendations to support the adoption of these advanced computational methods in vaccine production to accelerate innovation while maintaining product quality and safety.

The paper underscores Inno4Vac’s commitment to bridging the gap between scientific innovation and regulatory practice in the field of vaccine development.

Read the full article here: https://doi.org/10.1016/j.vaccine.2025.127170

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This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007799. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. This reflects the author's view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use made of the information contained therein.