It’s Never Too Early for Cold Chain Planning for Cellular Therapies
Cellular therapies — a category that includes regenerative medicine and immunotherapy — offer the potential to improve the practice of medicine and to fill unmet needs for patients with few or no treatment options. However, your supply chain team may have less experience with these products, which require new technologies, capabilities and resources that may not be available in-house. Moreover, distribution of these products can be challenging, as many must be shipped and stored at cryogenic temperatures.
In addition to strict temperature guidelines, these cellular-based therapies have multi-step supply chains that present a new layer of complexity to scheduling and track and trace. Whereas traditional pharmaceuticals have a linear supply chain model that is less time sensitive, many cellular therapies have a circular supply chain. For example, the manufacture of an autologous therapy requires obtaining cell materials from a patient, sending the materials to processing and manufacturing facilities, and then shipping the finished product back to the same investigator site for patient administration, leaving no room for error in tracking or traceability.
Source: Applied Clinical Trials