Extractable Leachable Testing for Cell and 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, Managing Director 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.

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