Current Progress in Approaches for The Safety Assessment of E&L

Title: Current Progress in Approaches for The Safety Assessment of E&L Presenter: Kim Li, PhD, DABT, MPH, Amgen Inc Summary: This Webinar will review the current progress in the risk management of extractables and leachables (E&L) impurities with focus on protein therapeutics. While toxicology assessments of E&L impurities are maturing toward best practices, their potential impact to product quality requires new approaches from the toxicologist toolbox. This webinar will discuss the in silico prediction of chemical functional groups that pose high risk of covalent binding, potentially leading to structural modifications of proteins and impact to quality attributes. Title: A Practical Approach to Extractables and Leachables Presenter: Erica J. Tullo, Technology Manager, E&L – Analytical Labs, West Pharmaceutical Service Summary: While many realize that regulatory agencies require extractable and leachable (E&L) information, many may not have knowledge of how to design an appropriate extractables study that will lead to proper selection of targets in leachables testing. During the extractables study, it is important to choose the most appropriate solvents and extraction conditions for the type of packaging components under evaluation. It is also important to consider a simulation study in which the entire system is assessed. Since leachables are typically a subset of extractables, the design of the extractables and simulation studies can significantly impact the subsequent leachables method development and monitoring. This presentation will highlight different considerations of each phase of E&L testing.