Finally, in the world of CAR-T, and, more generally, in that of cell therapy, it is notorious that “the product is the process”. There are multiple examples of manufacturing impacting both regulatory approvals (e.g. FDA’s refusal to file Ide-cel’s BLA in May 2020 and the more recent Liso-cel approval delay) and product performance (e.g. Kite touting 2-week turnaround time among their key differentiators). As manufacturers are subject to scrutiny like ever before, it is crucial to understand why, in the first place, manufacturing autologous cell therapies is so much more complicated than producing small molecules or biologics, why such processes are considered the industry’s most guarded secrets, and how difficult it is to incorporate new tech into existing operations. In the third of our three-part series on CAR-T therapies, Rohin Iyer, Global Program Manager for Cell & Gene Therapy at Cytiva (formerly GE Healthcare) gives us his take on the commercial and competitive angles around CAR T manufacturing and delivery.
