Charter
The Manufacturing Materials Safety and Technology (MMST) Working Group aims to discuss, clarify and guide regulatory expectations surrounding manufacturing and process controls during the early-stage development of CGTs. Subsequently, the MMST 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.
The MMST Working Group Aims to:
- 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 and commercialization.
2026 Project Focus
- Survey : Material & Supplier Characterization and Qualification
- Webinar: Uncommon Starting Materials
- Publication: Processing and Cryopreservation of Starting Materials
- Publication: Visible Particulate Risk Assessment Matrix for Cell-Based Advanced Therapies
Recent Publications