Supply Chain Management: PoC considerations, Product Tracking & Data Management
The unique supply chain involved in the production of cell therapies implies that effective methods of preservation are critical for commercial and clinical application of this form of therapy. Effective methods of preservation enable transportation amongst the different sites (collection, processing and administration), time for completion of safety and quality control testing as well as coordination of the therapy with patient care regimes. The preservation protocol consists of a series of steps (pre-freezing processing, introduction of a cryopreservation solution, freezing, storage, thawing and post-thaw assessment). Errors in each step can reduce post-thaw recovery and cell function. Key scientific concepts are described and resources to help those involved in the development of preservation protocols are provided.
Submitted for review: Aug 30 2017 Published: Dec 15 2017
Citation: Cell Gene Therapy Insights 2017; 3(10), 807-813.