The assessment of extractables and leachables can be 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.

The event aims to facilitate discussion on the most recent information on analytical techniques, regulatory updates, risk-based E&L programs, chemical characterization, and toxicological risk assessment among scientists, toxicologists, and E&L managers. It will also cover ISO 10993-18, medical device materials, analytical and safety thresholds, and customized systems for different product types.