- Dr. Robert E. Zoubek
- Senior Consultant
- Granzer Regulatory Consulting & Services, Germany
Dr. Zoubek is passionate biochemist with large experience in the mitigation of protein aggregation and degradation, and the effective design of formulation studies - an experience which he combines with his profound knowledge about the regulatory requirements in the US and EU for the different development stages. At Granzer Regulatory Consulting & Services Robert supports clients in all questions concerning drug development, manufacturing and quality control for biologics, biosimilars and ATMPs. Before Granzer, he owned several positions at Formycon, Germany, and GlycoForm. UK. As Director Scientific Affairs he led Formycon´s drug product development, formulation and analytical services and provided solutions for difficult-to-formulate proteins. Prior to that, he was Head of Protein Characterization & Preformulation and Head QC. Robert has seen many Peptides and Proteins exhibiting different propensities in aggregation. Over the years he gained a profound understanding about parameters causing aggregation, ways to mitigate aggregation, how to design studies effectively and the real challenges in aggregate analytics.
- Hans Rogl
- Manager Pharma Technical Regulatory Affairs
- Roche, Germany
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.