Robert Zoubek

Background

About Robert Zoubek

Regulatory CMC Expert for Cell & Gene Therapies, ATMPs incl Genome Editing, Biopharmaceuticals, Phages and Vaccines,**Induced Pluripotent Stem Cells (iPSC), CAR-T Cell, Autologous and Allologous Cell Therapies, Xenotranpslants **Gene-therapy Vectors such as AAV, AV, HHV, LV, Bacterial Vectors **Phage Therapies **Cell bank Development and Characterisation **Manufactuing Process Development, Pharmaceutical Control Strategy **Formulation, Drug Product Development and Compatibility Testings **Analytical Method Development and Method Validation **DS and DP Characterisation and Comparability Studies **Refence Standard Establishment **Quality Control and ICH-Stability Testing, Setting of Specification **Audits Dr Robert Zoubek joined Granzer Regulatory Consulting & Services GmbH in October 2013. Robert supports clients in all questions concerning regulatory affair requirements for drug substance and drug product development, manufacturing, quality control, comparability and analytics. He has in depth knowledge in European and US procedures with IMPD/ IND, MAA and BLA. Robert´s expertise covers gene and cell therapy, advanced therapeutic medical products, multiple vaccines, peptides and proteins. Robert has more than 20 years of experience in the development of pharmaceuticals. He is a recognized expert in biochemistry and cell biology with a number of publications and gives lectures and workshops. Until he joined Granzer Regulatory Consulting & Services GmbH, Robert worked in several positions at Formycon (former Scil Technology) and GlycoForm in the UK. Robert supervised more than 4 years the GMP certified QC-Labs at Formycon/Scil Technology. As Director Scientific Affairs he led Formycon´s drug product development and analytical services with focus on Formycon´s own Biosimilar development program with its Quality-by-Design approach. He was responsible on the CMC activities of the Biologics programmes, supervising method validations, release and ICH-stability testings. Prior to that he worked at GlycoForm in Abingdon, UK. In his academic years he was involved in industrial collaborations concerning the purification, characterisation and QC testing of biopharmaceuticals. Robert earned the PhD from the University of Erlangen-Nuremberg for his research on the wound-healing peptide and was awarded Master of Business Administration from the University of Manchester, UK. He also holds the title Diplom-Biologe (equivalent to M.Sc.) in cell biology from the University of Munich.