Subtopic 4 ‘VAXinS’ of Inno4Vac is developing a modular one-stop computational platform for in silico modelling of vaccine bio-manufacturing and stability testing to accelerate vaccine development.
Developing this comprehensive platform that links critical phases of the vaccine production process requires substantial efforts to allow connecting the unit operations. On a first level, unit operations may require linking components within themselves to create maximally realistic models; for example, combining mechanical bioreactor models with kinetic models of protein production in one operation. In order to make the resulting models computationally fast and applicable at manufacturing sites, models are further optimised. For example, computational fluid dynamics models can be transformed into compartment models in the platform, making calculations substantially faster. On a second level, following the optimisation of the unit operations, they need to be linked to one another, i.e., bringing together the upstream bioreactor with downstream purification processes such as centrifugation and chromatography. On a third level, plant-wide control mechanisms are being implemented.
As vaccine accessibility depends on vaccine stability, mathematical stability forecasting models are also a core component of this project and the platform and will be available in a user-friendly application.
The workshop focussed on advancing all aspects of integration, including the infrastructure that is used as a common platform, the technical requirements for making the models accessible there, exchange of the source code or software binaries, as well as defining parameters that go in and out of the models. An emphasis was also set on making appropriate use cases and examples available for users and showing how real world manufacturing will benefit from the final platform.
Next steps were discussed and include publishing the codes and models as well as demonstrating their usability in scientific papers. The team has achieved significant progress in integration and will continue to collaborate with regulatory experts, ensuring that the models are validated appropriately and are dependable, cost-effective, flexible, and safe.
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Dr. Reinhard Liebers (Project Manager at the European Vaccine Initiative)
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799 (Inno4Vac). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (www.imi.europa.eu). This communication reflects the author´s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.