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.