Supporting Off-site Manufactured Cell Therapy Products (“Pass-through Products”)

As the demand for cell therapies grows, healthcare center-based cell therapy laboratories are called upon to support clinical trials involving off-site manufactured cellular therapy products or “pass-through products.” Handling these products may involve shipping cellular starting material to the off-site manufacturing facility and/or receiving, storing, and distributing the final product. These processes may vary depending on the protocol. The increasing demand for support of these protocols and possibly infrequent handling of products for any given protocol raises concerns regarding maintaining competency, patient safety, and sustainability. This information may allow centers with cell therapy laboratories to understand what this support entails and for stakeholders to recognize the need for collaboration to streamline and standardize processes.
Objective: To survey the landscape of support for these “pass-through products” (descriptive project), which can include collection and shipment of cellular starting material and/or receipt, storage, and distribution of final cell therapy products.

Active

CT

Stroncek, Thibodeaux