Latest Advances in CAR-T Cell Manufacture & Clinical Developments
Guest Editor: Dr Bruce Levine, UPenn, USA
With the key milestone of the recent approval of the first CAR-T therapy this is undoubtedly an exciting time for the field. Now more than ever it is essential to move the conversation forward in addressing the cost-effective, scaleable manufacture of these therapies, their safety and clinical outcomes, as well as the latest developments in replicating clinical success in solid tumors. This issue will examine:
- The latest developments in CAR-T translation and manufacturing including alternate gene transfer methods to deliver CARs; novel gene editing approaches, advances in CAR design to improve safety and efficacy, and progress in creating an ‘off-the-shelf’ allogeneic CAR-T therapy.
- The tool and technology requirements for scaleable CAR-T manufacture, with perspectives on vein-to-vein supply chain needs and a future outlook on critical process parameters and manufacturing bottlenecks.
- Clinical and manufacturing-related regulatory considerations, licensing and ethical considerations in the translation of CAR-T therapies.