Anne B. Tolstrup, Ph.D., is an experienced biopharmaceutical industry professional with more than 25 years of experience in the areas of biologics cell line and process development, genetics analyses, scale-up, process performance qualification (PPQ), clinical and commercial GMP manufacturing. She has extensive experience working with regulatory agencies including FDA, EMA, and national agencies in Europe both with respect to IND and BLA filings as well as with technical on-site audits. Anne has been consulting for BioProcess Technology Consultants for the past couple of years. Prior to starting consultancy work, Anne worked in the Manufacturing Sciences Department at Biogen’s 15kL Large Scale Manufacturing site in Hillerød, Denmark, leading a team of cell culture, purification and process analytics scientific experts. Her responsibilities included global large-scale process transfers, multiple PPQs of late-stage novel biologics and biosimilars, process improvements, deviation investigations, GMP-audits and pre-approval inspections (PAIs) and daily scientific support of the GMP Drug Substance manufacturing of >10 different programs. Before joining Biogen, Anne was Cell Culture Development Director at Boehringer Ingelheim (BI), Germany where she headed the molecular biology, genetics analysis, cell line development and upstream process development and bioinformatics teams. She was accountable for all steps of process development from DNA to delivery of tox material, transfer and scale-up to GMP manufacturing operations. Her novel biologics molecule involvement includes monoclonal antibodies, fusion proteins, bi-specifics and novel non-IgG based formats. Prior to her time at BI, Anne worked in the Danish biotech industry for 15 years, as Director for Antibody Expression at Symphogen on recombinant antibody mixtures, Denmark and as Project Manager and Director at Pharmexa and Inoxell on drug discovery using retroviral vector libraries.
Anne is a frequently invited speaker at bioprocess conferences, and lectures at the international ESACT Animal Cell Technology Course every year. She is a member of the ESACT Executive Committee and involved in organizing the bi-annual ESACT conferences in various European cities. She serves as a reviewer for scientific journals and was Scientific Advisor for the eCHO EU consortium as well as adjunct professor at the Danish Technical University. Anne received her Masters and Ph.D. in Molecular and Cell Biology from the University of Aarhus, Denmark.