Dr. Robert Zoubek

Recognized expert for quality requirements of Gene and Cell Therapy products. Geographic areas: EU, Asia, Australia, Canada and US. Development stages: from early development, clinical development incl BLA/ MAA. Product classes: mRNA, LNP, DNA vector, Lentivirus, AAV, Retrovirus, Herpesvirus, HIV-based vector, CAR-T, iPSC, gene editing, CRISP, CAS, and many others.

Regulatory Strategy on Drug Development and Devices & Diagnostics Regulatory Procedures Authority Meetings Electronic Submissions Project Management

Drug development strategies for Innovators and Biosimilars Research on issues of pharmaceutical drug development (aggregation, charge &hydrophobic heterogeneity, immunogenicity etc.) Evaluation and implementation of innovative technogies and processes. Development of interdisciplinary research programs between industry and academics. Clients´ contact for drug development strategies with regard to regulatory and operational aspects.

**GMP-Analytics and Quality Control / **Stability studies and compatibility testings / **Protein characterisation and comparability studies / **Team, project and cost center management / **Scientific and disciplinary responsibility for 6 employees / **Employee and Lab development / Business strategies and positioning. Customer acquisition.

Method band width: SEC; RPC; HILIC; IEC; PAGE; IEF; Microscope; Turbidimetry; ELISA; Western blot; Light obscuration; AF4-MALLS; SLS; DLS; LC-MS; BioLayer Interferometry; FT-IR; DSC; DSF; CE **GMP-Analytics and Quality Control / **Stability studies and compatibility testings / **Protein characterisation and comparability studies / **Team and project management / **Scientific and disciplinary responsibility for 3 employees / **Employee and Lab development /

**Protein expression and Purification / **Refolding and Formulation / **Chemical modification and Analytics

PostDoc Development of analytical methods for quality control pharmaceutical peptide FDA acceptable bioassays corporation with US Pharma company

Management

Purification, characterization and engineering of pharmazeutically active peptides. Tissue regeneration, wound healing, neo-vascularization.

Enzyme kinetics, protein biochemistry, cell biology, cancer research, apoptosis