By Carla Reed, president, New Creed LLC
In November 2018, I wrote an article about establishing a supply chain for autologous cell therapies — those formulated using a patient’s own cells. This partner piece highlights considerations that need to be taken into account when developing a commercialization and supply chain strategy for allogeneic cell therapies, in which cells from a single donor are expanded and used to treat multiple patients.
As with autologous therapies, allogeneic products are normally developed to address the needs of a relatively small patient population, with very specific indications. Allogeneic therapies offer some obvious advantages from the production perspective. However, unlike autologous therapies — where the patient and their location are known from the outset — allogeneic therapies can be distributed to patients across a wide geographic area. In many cases, the point of care for a commercial allogeneic therapy is in a different location than the product’s clinical trials sites. This presents challenges that are unique to allogeneic therapies, not the least of which is identifying where to position product inventory and distribution channels for delivery to an undefined network of caregivers.
In most cases, several CMOs and other partners contribute to the allogeneic production process, so at least the different links in the upstream supply chain are known. The challenge becomes understanding the storage and distribution environment necessary to deliver product to the patient — and what capabilities and distribution partners are needed to ensure the safety and integrity of product across the chain of custody.