Inno4Vac Regulatory Workshop: ‘Utilising in silico models to expedite vaccine development, testing, and lifecycle management”

On 27 May, Inno4Vac held a workshop in Brussels with regulators and experts from leading industry, academic, and non-governmental organisations to discuss the integration of modelling and virtual platforms to improve the vaccine production process.

 May 2025

The workshop featured discussions on the role of computational modelling in the vaccine manufacturing process. Topics covered the development of advanced modelling approaches to support vaccine stability assessment. Inno4Vac partners presented a novel framework using Bayesian methods and kinetic modelling to enhance shelf-life predictions from both long-term and accelerated data. The workshop also covered modelling of upstream bioreactor dynamics and downstream purification processes as chromatography and centrifugation. Developing, validating and disseminating these tools is a key component of the Inno4Vac project. The modelling of these systems is complex but has significant potential to increase the vaccine pipeline efficiency and final product quality, especially when combined with quality-by-design principles. However, it is essential to ensure that these processes comply with regulatory expectations. 

Therefore, the European Vaccine Initiative (EVI) coordinated the meeting between stakeholders from the vaccine industry, academic researchers, and regulators. Participants included Inno4Vac partners from GlaxoSmithKline, Sciensano, Cencora Pharmalex, MCT Bioseparation, Paul-Ehrlich-Institut, Sanofi, Denmark Technical University, Forschungszentrum Jülich and University College London, alongside representatives from the Coalition for Epidemic Preparedness (CEPI) and regulators from German, Belgian, Austrian, Norwegian, Spanish, Swedish, and Turkish public agencies. 

Workshop coordinator Irina Meln reflected on the event: “Inno4Vac-developed innovative modelling approaches are designed to accelerate and improve the reliability of vaccine development and manufacturing. Ultimately, they contribute to enhanced regulatory confidence and greater efficiency throughout the vaccine production process.”

One of the standout moments was the keynote by Renske Hesselink from CEPI, who spoke about stability preparedness and modelling in the context of rapid outbreak response. Her talk underscored the importance of adaptable, forward-looking approaches in global health, aligning well with Inno4Vac’s ambition to develop innovative models that streamline vaccine biomanufacturing.

The lessons from this workshop will be incorporated in the ongoing Inno4Vac effort to create improved vaccine manufacturing tools and workflows. 

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.