Kristin Treece
Senior Scientist
Kristin Treece received her Ph.D. from West Virginia University in Applied Analytical Chemistry. Following graduation, Kristin held a post-doctoral research associateship at Los Alamos National Laboratory where she performed both targeted and untargeted screening of high explosive formulations as well as structural elucidation of impurities. These fined-tuned skills made transitioning into the Extractable and Leachable industry an easy decision.
Since her time with Element- Bend, Kristin has specialized in and is the resident small molecule structural elucidation SME. She regularly performs low resolution and high-resolution structural elucidation interpretations of both GC-MS and LC-MS data. Kristin also spends time processing and deconvoluting complex GC and LC screening data. Customers have also collaborated with her during studies as her expertise in method development and validation is an asset to both Element-Bend and their customers.
Kristin has also began performing industry-leading and relevant research projects in response to FDA “hot-topics” including uncertainty factors and bad actors like PFAS. She is also working to answer internal questions regarding sample preparation effects on complex drug matrices.
DAY 2: February 28th, 2025
SESSION: 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.
