BPS 2023
Aggregation Analytics- a complex topic
Andreas Stadelmaier
Senior Group Leader R&D, Bachem
ABSTRACT
Aggregation is a complex and heterogenous process for peptides. The individual trigger for peptide aggregation is peptide specific and can be induced by standard manufacturing conditions. Therefore, it is important to evaluate and manage the manufacturing process to produce physically stable drug substances. In this talk the presenter will share Bachem’s analytical expertise on peptide aggregation and how to avoid it through optimized downstream process conditions.
BIO
Dr. Andreas Stadelmaier is an organic chemist with over 20 years of experience in the industry of therapeutic drug substances from numerous different roles and positions.
Andreas received his Ph.D. in Organic Chemistry under the supervision of Prof. Richard R. Schmidt at the university of Konstanz, Germany. In his dissertation he focused on the synthesis of carbohydrates such as oligosaccharides, glycerophospholipids and glycopeptides.
In 2003 Andreas started his professional career as head of R&D at ChemCon GmbH in Freiburg, Germany, a CMO specialized primarily on custom manufacturing of small organic molecule APIs. He then joined Bachem AG in Bubendorf, Switzerland in 2011, where he was initially responsible for large scale purification of peptides. Andreas later transferred to Bachem R&D as Sr. Group Leader for downstream process development, and since then works on a wide variety of projects. Dr. Stadelmaier specializes on the isolation of peptide APIs for large-scale manufacturing, such as precipitation, lyophilization or spray drying, and is also an expert on related topics such as aggregation.