Hanne Bak

A chemical engineer by training with a Ph.D. from The Technical University of Denmark, Hanne Bak started at Regeneron as a Research Engineer. First Hanne enjoyed increasing levels of responsibility within Purification Development while also developing an Analytical team supporting all process development activities. In 2015, Hanne transitioned into overall leadership of the Preclinical Manufacturing and Process Development (PMPD) department, the critical link between Research & Development and Manufacturing. In this role, she is responsible for all aspects of process development ranging from (i) molecule candidate and cell line assessment and selection, through (ii) development of initial speed to clinic manufacturing process for early clinical trials to (iii) the development of the intended commercial processes applying the principles of Quality by Design (QbD), (iv) technology transfer to Regeneron’s GMP manufacturing facilities in Rensselaer, NY and Raheen, Ireland and, (v) support of Regulatory strategy and filings globally. Since joining Regeneron, Hanne and her team have been involved in the development and technology transfer of over 70 novel manufacturing processes to eleven different Regeneron manufacturing suites, provided subject matter expertise for technology transfers to external contract manufacturing and partner sites, and contributed to or fully developed manufacturing processes for all of Regeneron’s eight (8) approved pharmaceutical drugs. In recent years, Hanne has enjoyed the learning and challenges a pipeline diversifying beyond protein-based therapeutic modalities is offering.