Armin Hauk - uventia

Armin Hauk

Armin Hauk

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).

4th Annual Extractables & Leachables
March 7, 2024
What is next in testing and analyzing for extractables and leachables in biopharmaceutical development and release? Recording of 2 days event sessions [18 video sessions].

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.

Speaker Details
Speaker Details