CMC Biologics Consulting

Lars Foldager, PhD

Throughout my career, I have been working with bioprocess development and manufacturing in the biotech and biopharmaceutical industry.

Working as CMC Biologics Director at Lundbeck for ~16 years, I have:

• significant experience with all aspects of CMC Biologics Development, being overall responsible for the CMC Development of Biopharmaceutical projects (including mAbs, glycoproteins, and recombinant therapeutic vaccines),
• solid experience with outsourcing of CMC activities, including identification, evaluation and contract negotiation with Contract Development and Manufacturing Organizations,
• headed cross-functional Teams defining and executing the CMC strategy, and facilitated finding technical solutions,
• gained considerable knowledge of ICH Quality and CMC Regulatory requirements.

Previous experience includes commercial API bulk production of human growth hormone at Novo Nordisk, and bioprocess development, production support, scale up, Tech Transfer and design through start-up and commissioning of a Fermentation Pilot Plant at Chr Hansen.

Professional experience

2002 - 2018: CMC Biologics Director / Head of CMC Biologics, Lundbeck A/S

2001 - 2002: Production Manager, hGH Bulk Production F&R, Novo Nordisk A/S

1986 - 2000: Scientist / Project Manager, Process Science Dept., Chr. Hansen A/S

Education

Ph.D., Institute of Biotechnology, Technical University of Denmark

M.Sc., Chemical Engineering, Technical University of Denmark