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Extractables and Leachables: Regulatory Expectations to Laboratory Assessment

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Contributors

  • Michael Jahn (Lonza Pharma & Biotech)

    Since 2016, Dr. Michael Jahn has led the Forensic Chemistry group for Lonza Pharma & Biotech’s Drug Product Services team. In this position, Michael uses his extensive analytical and regulatory knowledge of Extractables & Leachables (E&L) to support Lonza Pharma Biotech’s customers in the biopharmaceutical industry. Prior to Lonza, he spent 11 years in the pharmaceutical industry working for companies including Ciba Expert Services and Novartis. During that time, Michael was responsible for setting up and leading analytical laboratories that specialized in trace analysis and structure elucidation with a strong focus on E&L testing. While at Novartis Biologics, Michael implemented the strategy for E&L assessment of all manufacturing, storage and administration materials. This work contributed to a number of successful INDs/IMPDs and BLAs.

June 14, 2018
Thu 12:30 PM EDT

Duration 1H 30M

This live web event has ended.