Extractables and Leachables have been used interchangeablely for too long. Are we still confused?

The terminologies of “Extractable” and “Leachable” have been used interchangeably to describe test data from a study which fall in between a grey zone of typical “Extractable” or “Simulation” and “Leachable” study. During this webinar, we will explore to better understand what are the key challenges with case study and survey this grey area to capture the view of all participants.”
Presented by Ken Wong, Deputy Director at Sanofi Pasteur
Ken Wong is a Deputy Director of Process Technology Platform at Sanofi Pasteur. Serving as the Swiftwater site extractables and leachables (E&L) SME but also provide E&L supports to all global sites. His 19-year in biopharma professional career has ranged from R&D to development and commercialization to cGMP manufacturing support. For the last 17 years, he has specialized in E&L in wide range of packaging systems (including lyophilized powders, oral liquids, creams, ophthalmic solutions, transdermal, bio-surgical delivery systems, injectable devices, and inhalation devices for aerosol, solutions and powders). In the last 10 years, he has been heavily involved with Single-Use Technology and actively participating in Disposable workstreams of BioPhorum Operations Group (BPOG), the USP <665> Expert Panel and the ELSIE material working group.
Sponsored by West Pharmaceutical Services

Followed by Building a Bridge to Leachable Assessment
Extractable data is a practical guide to support selection of components used in drug product container closure systems and to understand potential for leachables. Standardization of extractables testing is a topic of interest in the pharmaceutical industry and debate in the scientific community, however; the challenge for standardized tests is to verify the extent of data and type of extractions needed to drive the best decisions. As a starting point, comparative extractable data can indicate differences, but this may not be relevant to end use application. According to USP <1663> informational chapter on extractables assessment, the design of an extraction study is dictated by the purpose of the extractables assessment. This presentation will put into practice the overarching principles of USP <1663> for developing extractable study designs. Three case studies will be given representing risk of leachables across product lifecycle. Data will be shown related to the selection process, post approval changes, and considerations for biologic product quality.
Presented by Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services

Dr. DeCou’s current position is that of Extractable and Leachables Technology Manager at West Pharmaceutical Services. His primary responsibility is to develop and increase knowledge of industry & technology as it applies to extractables and leachables and to effectively support West in identifying and growing future analytical expertise. Don has been working in the pharmaceutical industry for over 20 years with increasing responsibilities relating to extractables and leachables in roles ranging from analyst, supervisor, subject matter expert, and manager. He has worked for companies such as 3M (in their Pharmaceuticals /Drug Delivery Systems divisions), PPD, Covance, Alcami, and Pace Analytical. He received his Ph.D. in Analytical Chemistry from Kansas State University in 1993.