Digitization Of The Supply Chain: Challenges In Scaling Up Cell & Gene Therapy

Personalized medicine has become a reality for many conditions, for example read about one of the first C&G therapy patients, Novartis patient #1: Emily Whitehead. The list of C&G therapies is expanding fast as more trials are succeeded by more FDA approvals.

Even in patients with the same disease, generic medicines will commonly help some patients, while having minimal effects on few and potentially adverse effects on others. In contrast, new personalized treatments such as C&G therapy, based on our improved understanding of genetics, the immune system and stem cells, are specifically designed and manufactured for individual patients. This is a unique difference to traditional pharmaceutical manufacturing because C&G therapy is made to order rather than made to stock. Additionally, for each patient, the manufacturing process starts with patient-specific material and requires sensitive inbound and outbound logistics.