5th Annual Extractables & Leachables Summit 2025

The assessment of extractables and leachables is a critical step in the biopharmaceutical development process. The interactions between pharmaceutical products and drug delivery systems, bioprocess manufacturing systems, and container closing systems are of special concern for regulatory bodies. Therefore, it is necessary to carefully examine the migration of mobile molecules from the materials and components utilized in the production and storage of pharmaceuticals. We organize a virtual conference to facilitate discussion on the most recent analytical techniques, regulatory updates, risk-based E&L programs, chemical characterization and toxicological risk assessment among scientists, toxicologists and E&L managers. We also cover ISO 10993-18, medical device materials, analytical and safety thresholds and customized systems for different product types.

Topics: Updated regulatory guidelines for E&L testing, How to implement effective E&L study designs, Risk assessing extractables and leachables, Toxicological Risk Assessment, Single Use Systems (SUS), drug products, X-ray vs. gamma, rubber closures, E&L testing for medical devices, bioprocess equipment, Testing for E&L in packaging materials, E&L assessment of cell and gene therapies