Frank B. Nygaard, PhD

Symphogen
CMC Director, Drug Substance Development
Frank Nygaard has more than 14 years of R&D experience from the biotech industry with a broad background within manufacturing and analysis of protein therapeutics including monoclonal antibodies. He holds an M.Sc. in biochemistry and a Ph.D. degree in protein chemistry from the University of Copenhagen.
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Frank Nygaard has taken key responsibilities for process development and technology transfer to contract manufacturing organisations (CMOs) for manufacturing of clinical trial material. This includes upstream and downstream processes as well as final fill and finish of drug product, where he has been involved in troubleshooting activities during cGMP manufacturing at CMOs. Furthermore, Frank has been working closely with QA functions to prepare quality agreements between sponsor and CMOs/CROs.
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Through his professional career, Frank Nygaard has acquired a profound knowledge and insight into chemistry, manufacturing and controls (CMC) requirements for protein therapeutics within manufacturing and analysis. He has also been a contributing author to the CMC part of regulatory filings for various clinical trial authorisations (CTA) and investigational new drugs (IND).
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Frank Nygaard has proactively been pursuing the development of cost-effective manufacturing processes suitable for commercial manufacturing. He has played a key role in planning of manufacturing scenarios for both early and late clinical development. This includes preparation of requests for proposals as well as screening and evaluation of suitable manufacturing organisations.

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