BioIVT’s Trevor Smith, MS, MBA, product manager, immune cells, describes necessary considerations when preparing to manufacture a cell or gene therapy, from starting materials to safety endpoints.
Key insights:
- The quality of cell & gene therapy starting materials reliably determines the success of generating an advanced therapy
- To avoid delay in bringing therapies to market, therapy developers should articulate their ideal donor demographics upfront and work with providers who have characterised their donors to a level that can accommodate their customers’ needs.
- The explosive growth of cell & gene therapies in development has created a strain on CDMOs and CTOs – which were further burdened during the COVID-19 pandemic.
With more than a decade of success driven primarily by chimeric antigen receptor (CAR) T cell endpoints, the field of cell & gene therapy is seeing unprecedented growth globally. Europe has been positioning itself to facilitate the development of advanced therapeutics, recently courting Bristol Myers Squibb (BMS) to construct its CAR T cell therapy production centre in Leiden Bio Science Park in the Netherlands. To keep pace with the industry, developers in Europe would do well to consider the supply chain for their starting materials as well as the safety and efficacy of the final therapeutic product.