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ICYMI: 21 Critical Supply Chain Tips for Cell Therapies

From holiday weekends to large health center campuses, find out where risk may be lurking in the collection, manufacturing and delivery of cell therapies. Essential to success are chain of identity (COI), chain of custody (COC) and chain of condition (COCn).

It’s a long-established fact that in healthcare, supply chains are incredibly complex. Time- and temperature-sensitive drugs add extra layers of intricacy and potential problems for product quality.

Critical areas for cell therapies are chain of identity (COI), chain of custody (COC) and chain of condition (COCn) (See sidebar below, The Data Trail, for more detail). “This could be your father’s cells, your child’s. The integrity of the sample must be maintained throughout the process,” said Patricia M. Seymour, MBA, CSCPManaging Director in the BioProcess Technology Group of BDO USA. She spoke at the 2019 PDA Cell and Gene Therapy Conference in May, highlighting that overcoming supply chain challenges is fundamental to cell therapy manufacturing.

Some of the challenges center around scalability and patient demand, which can be hard to forecast. Additionally there are multiple data collection systems that must be integrated—data integrity and tracking are key. As Seymour noted, “It’s quite an ecosystem to coordinate from start to finish. It’s not just all about the biology. IT will be critical to the supply chain—all of it has to work in great synchrony.”

Needle-to-Needle: The Autologous Cell Therapy Supply Chain

  1. Collection: collect and control the patient’s sample.
  2. Manufacturing: manipulate or modify the cell product.
  3. Treatment: infuse or dose the product back to the patient, with continued monitoring.

Seymour’s tips follow, categorized by activity: