Extractables And Leachables In Advanced Therapy Medicinal Products: An Initial Industry Viewpoint

Advanced therapy medicinal products (ATMPs), including cell and gene therapies, are reshaping patient care—but their complexity demands new regulatory clarity and manufacturing best practices. One critical challenge is assessing extractables and leachables (E&Ls) in single-use systems, which may release compounds into the process stream. While E&L qualification methods are well-established for traditional biologics, their adequacy for ATMPs remains uncertain. Industry experts, convened by BioPhorum, have begun exploring this gap through collaborative discussions and surveys. Key insights include the lack of detailed regulatory guidance, the need for tailored extraction protocols, and the importance of robust quality risk management. These early findings highlight the unique demands of ATMP manufacturing and lay the groundwork for more targeted E&L studies.

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