Armin Hauk
Principal Scientist
Armin Hauk has a position as Principal Scientist at Sartorius Stedim Biotech GmbH since 2016. Before that he was over 20 years active as head of laboratories for organic trace-analysis, GLP & GMP analytics in Ciba-Geigy, Novartis, and Ciba Specialty Chemicals. For Intertek, Switzerland he worked as consultant and Qualified Person (QP). Armin is a lecturer and trainer in E&L at conferences and seminars and is a member of various industry consortia (BPSA, BPOG, DECHEMA, and MIT BioMan). He is chairperson of the Pharmacopeia expert group 16 in the European Directorate for Quality of Medicine (EDQM).
DAY 1: MARCH 7th, 2024
SESSION: Extractables and leachables from single-use systems and their assessment in advanced therapy medicinal product (ATMP) production
◆ E&L safety assessment in cell and gene therapies (CGT) is challenging.
◆ While suitable extractables data are available, exposure estimations to patients and the ex vivo manipulated biological material need to be improved by exposure modelling..
◆ Additionally, data for toxicological relevant end points for the ex vivo manipulated cells are required.
◆ It will be shown that morphological profiling with a cell painting assays (CPA) using human cells allows to identify potential detrimental effects relevant for E&L safety assessments.
