Chief & Director, Cellular Therapy Program Children's National Hospital
The primary purpose of any cell therapy process is the delivery of a safe and effective product to the patient. Cell therapies are a unique drug product with product-specific clinical administration considerations. Regulatory compliance, chain-of-custody, and predictable patient outcomes are critical. Ownership of the cell therapy product at each point in the supply chain of custody and the party responsible for the drug substance, drug product or intermediates throughout the potentially complex operational processing steps are key challenges. Post-production requirements of therapeutic cells should facilitate delivering a finished cell therapy product reducing variability and preventing contamination. Automated technology supports process integration and data-driven accountability. Innovations in the packaging and storage of cellular suspensions can limit contamination risk. Transport and shipping solutions can track or prevent any damage from temperature excursions. Cell therapy development should include product formulation and stability strategies, supply chain and clinical handling and administration. Post-production technologies should include process integration to streamline and improve last mile procedures so that they synchronize into upstream processes. This presentation will discuss automated technology, packaging innovations and transport solutions.
A speaker will be identified if this session is chosen. This was submitted by the Gene and Cell Therapy Products (CMC Subteam) Community.
Learning Objectives:
Identify issues that can affect cell therapy post-production process
Describe the tools available to address post-production issues