17 Jul 2025
Ask Our Expert: Extractables & Leachables Testing for Cell & Gene Therapies
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Ask Our Expert: Extractables & Leachables Testing for
Cell & Gene Therapies
E&L studies play a pivotal role in ensuring safety, efficacy, and regulatory compliance of gene therapy or cell-based medicinal products.
Our expert in pharmaceutical regulatory analysis and extractable leachables testing, Dr. Tino Otte, Director of Sales & Consulting at Intertek Switzerland, explores why these studies are indispensable for ATMPs, the distinctions between E&L for advanced therapies versus traditional small molecules, relevant guidance for assessing extractables in cell and gene therapies (CGTs), and the key considerations for implementing effective leachable programs.
Unlock the full insights and enhance your understanding by downloading our comprehensive article now!
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TEL: +44 (0)116 296 1620
EMAIL: pharma.services@intertek.com