Case Study: Migration of PFAS from Fluoropolymers used as Single-Use Processing Components in the Manufacture of Cell & Gene Therapy Products

In the rapidly advancing field of Cell & Gene Therapy (CGT) manufacturing, the use of single-use processing components is integral for efficiency and flexibility. Fluoropolymers, such as FEP, have been commonly used as materials of construction for these components and commonly known for being inert. However, concerns have emerged regarding the potential migration of Per- and Polyfluoroalkyl Substances (PFAS) from fluoropolymer contact materials into therapeutic products. When PFAS are detected in E&L studies, they require thorough investigation to ensure the safety and efficacy of CGT products.

This presentation will dive into a case study for the identification of PFAS from a commonly used single-use material, FEP. The case study will cover factors influencing migration, potential impacts on patient safety and regulatory feedback received with regards to PFA detection in CGT E&L studies. This presentation seeks to facilitate a collaborative dialogue within the CGT community, fostering awareness, and encouraging the development of industry-wide standards to ensure the continued success and safety of Cell & Gene Therapy products.