Karin Sewerin

QA and CMC expert

Karin Sewerin is a Sr Consultant at BioPharmaLinx AB working with quality strategy and regulatory advice for development and registration of Biopharmaceuticals. She has over 30 years of industrial experience from Kabi-Pharmacia and AstraZeneca in Sweden and Genentech in USA.  Karin has worked with development and validation of analytical methods for in process control and release testing for products in clinical trials and for registration. She has also work with process validation, process characterization, technology transfers for clinical and marketed products, and definition and development of Quality by Design for Biotechnology derived products in industrial and regulatory groups. Karin has participated in industry focal groups in development of several ICH guidelines. She holds a PhD in Pharmaceutical Biochemistry at the University of Uppsala, Sweden.