Mastering Scalability and Sustainability of Cell and Gene Therapy Manufacturing

Viral vectors, particularly adeno-associated viruses (AAV), are pivotal in the production of cell and gene therapies, with their importance expected to grow as the field shifts toward in vivo therapies. However, achieving high-yield AAV production at commercial scales remains a significant challenge.

This project aims to address this issue by developing an innovative bioprocessing system capable of upstream and downstream processing across three log scales (10ml, 100ml, 1000ml) validated against a 5-litre bioreactor. The integrated downstream processing will employ enhanced AAV-specific chromatography columns designed to maximize vector recovery.

The system will measure viral titres derived from both E. coli and HEK293 cells to ensure flexibility and robustness across different production platforms. A key component of this work will be the development of a predictive model that integrates real-time data from the bioprocessing system with historical data, providing insights into expected yields at various scales. This model will enable process development scientists to significantly reduce the number and size of experiments required, thereby accelerating the development of clinical trial material and full-scale manufacturing and significant improving sustainability.

In addition to optimizing production efficiency, this project will also develop a sustainability model, quantifying the environmental benefits of this scalable, streamlined bioprocessing strategy. The result will be a comprehensive, predictive, and environmentally responsible biomanufacturing solution for viral vector production.