Extractables and Leachables have been used interchangeablely for too long. Are w

Presented by

Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharma

About this talk

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 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 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 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

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