It is 2020, and it seems that CAR-T is still the new kid on the block in the eyes of many pharmaceutical companies. It should not come as a surprise how many Biopharma entities are still participating in the race to develop the next blockbuster CAR-T therapeutic, even amidst this pandemic crisis. Some of the big names, companies such as Amgen, Novartis, Kite Pharma, and Celgene (a BMS company) are actively developing their CAR-T cell pipeline. This recent boom in personalized medicine is here to stay, and the Life Science industry is quickly looking to adopt these new platforms. And while there is contagious excitement for a treatment that will address a pathology that has undoubtedly touched every one of us, there are still several major hurdles that Biopharma companies will have to address. This innovative treatment will require companies to rethink their approach towards the general chemistry, manufacturing, and control (CMC) standards that they have previously used throughout the drug development process.

CAR-T treatment is always focused on a single patient, so the route to drug approval will have to majorly change. It will also invariably rearrange the structure of the typical drug manufacturing process. PMs within the life sciences will find themselves seeking innovative solutions to bypass the stringent constraints of generalized pharma production. And this is only the beginning of the challenges that will be faced. From a technical standpoint, acquiring an adequate amount of T cells can be difficult and the development of personalized batches leading to the finalized product can involve a lengthy and individualized manufacturing process. Biopharma will have to adapt to the new GMP requirements that CAR-T will bring. Change is never easy, but if it can bring about a new approach to public enemy number one, cancer, then I am a thousand percent in.