J. Susanne Becker
Head of Extractables and Leachables Labs
J. Susanne Becker did her Ph.D. at the University of Konstanz in Analytical Chemistry in the field of Proteomics and Organic Mass Spectrometry. After several years’ experience in the pharmaceutical industry at Aeropharm and Baxter as Analytical Expert and Project Manager, she joined Intertek (Schweiz) AG in April 2016, where she is working as Project leader in E&L and since 2021 as Head of Extractables and Leachables Labs.
DAY 1: MARCH 7th, 2024
SESSION: From Extractables Study to Leachables Study – from screening methods to validated target methods for Stability Testing in E&L
◆ Set of Extractables Study under realistic worst-case conditions.
◆ Leachables Simulation Study using drug substance/product solution.
◆ Selections of target compounds, method development and validation according to ICH.
◆ Case studies showing problems and possible solutions.
