Karin Sewerin

Karin Sewerin, PhD, initially worked with ITB-MED as a consultant in CMC regulatory affairs and Quality Assurance, and joined the company in 2024 as an advisor in CMC regulatory affairs. She has over 40 years of experience in international biopharmaceutical industry. Before joining ITB-MED she worked as a CMC and regulatory consultant in development of biotechnology derived products. She has previously worked at Kabi-Pharmacia and AstraZeneca in Sweden, holding positions as Sr scientist, Head of QC, Global Head of Regulatory CMC for Biologics, and at Genentech in USA as Head of QC for Development Products and Director of CMC Regulatory Affairs.

 

Karin has worked with product design and selection of candidate drugs, protein characterization, development and validation of analytical methods for products in clinical trials and for commercial use. She has worked with design of control strategies including process validation, process characterization, technology transfers of clinical and marketed products and control of biotechnology derived products, and with regulatory submissions for clinical trials, registration and for life cycle management. She holds a PhD in Pharmaceutical Biochemistry at the University of Uppsala, Sweden.