Stephan Krause


Dr. Stephan Krause is currently to Director of Product Quality for AstraZeneca Biologics. He is an accomplished leader of industry quality-focused task forces to improve and standardize best practices. His breadth of exposure to various biological products includes mAbs, ADCs, Coagulation Factors, Vaccines, ATMPs, and Biosimilars. He has 20 years of management experience in the development, manufacture, and testing of commercial and clinical biologics and drug-delivery device combination products.

Stephan has been PDA Task Force Chair/Leader for: Analytical Method Validation and Transfers for Biologics (TR 57, 2012); Biological Product IMP Specification Setting (2015); Biosimilars Initiative (2015-19); ANSI Standard for Analytical Methods (since 2021). Stephan is currently a member of PDA’s Board of Directors (since 2019), co-chair of the ATMP Advisory Board (since 2020), co-leader of the Vaccine Development Initiative (since 2021), and a member of PDA’s BioAB (since 2014) and RAQAB (since 2017). He won five industry association awards (2008-2020) and was invited by FDA to represent an industry perspective for analytical method lifecycle steps (2012) and for accelerated product development (2015). He often chairs conferences and workshops and has many notable publications.