Current Progress in Approaches for The Safety Assessment of Extractables and Leachables

06th April 2018 | 10AM PT | Kim Li, PhD, DABT, MPH, Amgen Inc. and Erica J. Tullo, Technology Manager, E&L - Analytical Labs, West Pharmaceutical Services |WATCH FOR FREE

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.

Presented by Kim Li, PhD, DABT, MPH, Amgen Inc.

Dr. Li is a board certified toxicologist with broad experience in R&D and Operations. She joined Amgen in 2004 and is currently the lead toxicologist on the extractables and leachables programs on container closure systems, drug delivery devices and single-use bioprocess systems. Kim is the chair of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium. As a member of the Association for the Advancement of Medical Instrumentation (AAMI) Biological Evaluation Committee, Kim serves as the US expert to ISO/TC 194.




Sponsored by West Pharmaceutical Services


Presented by Erica J. Tullo,  Technology Manager, E&L – Analytical Labs, West Pharmaceutical Services

Ms. Tullo has over nine years of experience in extractable and leachable analysis of container closure and delivery systems and devices. She currently serves as Technology Manager for Extractables and Leachables (E&L) at West Pharmaceutical Services, Inc., where the focus of her role is to collaborate across industry to further scientific knowledge and determine the most current testing technology in E&L. Prior to this role, she was a group leader in E&L at Eurofins Lancaster Laboratories.

Ms. Tullo received a Ph.D. in Applied Science and a M.S. in Chemistry from the College of William and Mary. While at William and Mary, she focused on determining various gas-phase thermochemical properties of a variety of organic and biological molecules, including constrained diamines and amino acids, using mass spectrometry. She performed high-level ab initio and density functional theory calculations in support of the experimental studies. Ms. Tullo is also the author/co-author of several articles on this topic and has presented the work at various conferences. She is an active participant in the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) working group.

A Practical Approach to Extractables and Leachables

Abstract:  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.

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