Charter
The Particulates Working Group aims to discuss, clarify and guide regulatory expectations surrounding manufacturing and process controls during the early-stage development of CGTs. Subsequently, the Particulates Working Group seeks to define how raw materials, manufacturing and container-closure components, and foreign particulate matter should be characterized and controlled during product development and throughout the clinical phases through the lens of form, fit, function. Special considerations will be paid to the effect of manufacturing materials on the quality and patient safety of CGTs in the era of plastics and Single-Use Systems.
Topic area of consideration include:
- Critical materials
- Manufacturing materials and components
- Primary container-closure systems
- Extractables and Leachables
- Container closure integrity
- Visual inspection
- Foreign particulate matter in the visible range
- Sub-visible particulate matter
- Cryopreservation from a container perspective
Aims:
- Assess the current industry gaps and concerns surrounding the characterization and control of manufacturing materials, processes, and container-closure systems intended for CGTs.
- Define a series of best practices for characterizing manufacturing materials and container-closure systems for CGTs during early-stage product development, focusing on deep-cold and cryogenically-stored products.
- Construct a framework for continual materials and process control that carries through late-stage development
Projects & Objectives
- White papers: The Particulates WG currently has an opinion piece under review with ISCT Journal, Cytotherapy. Stay tuned for the publication.
- ISCT Annual Meeting: Most recently held a roundtable at the ISCT 2023 Annual Meeting in Paris.
- Educational Webinars: The Particulates WG are working on an open-access webinar for Q4 2023
Recent Publications