Dr. Hans Rogl is Manager of Pharma Technical Regulatory Affairs, at Roche, Germany. He has worked in the biopharmaceutical industry with focus on downstream processing of therapeutic proteins since more than 15 years. Hans had positions in process development since 2008 at Boehringer and Roche. Currently his focus areas are on Biosimilars and process characterization and QbD. When starting his career at Roche he had the opportunity to gain experience in GMP manufacturing of therapeutic proteins for clinical use as well as marketed products which were expressed in mammalian and E.coli cells. He was a post-doctoral fellow at the Centre d’Immunologie de Marseille-Luminy with Dr. Bernard Malissen investigating T-cell activation. Hans received his Ph.D. on refolding membrane proteins under the guidance of Prof. Werner Kühlbrandt at the Max-Planck Institute of Biophysics in Frankfurt / Main.