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Kelly Donovan

Director
KBI Biopharma
Louisville, Colorado

Kelly Donovan is a Director at KBI Biopharma, where she leads the Characterization Services team at the Louisville, Colorado site. With over 20 years of experience in product characterization of biotherapeutics, Kelly has built a career spanning both contract development and manufacturing organizations (CDMOs) and innovator companies.

Her team at KBI comprises experts in biochemical separations, bioassays, and mass spectrometry, supporting comprehensive analytical capabilities for biopharmaceutical development. Kelly’s expertise lies in the Elucidation of Structure section of the Marketing Application, a critical component in regulatory submissions.

Throughout her career, Kelly has contributed to the successful commercialization of numerous biologics, guiding programs from Investigational New Drug (IND) applications through Biologics License Applications (BLA). She is well-versed in regulatory expectations and has a proven track record of delivering high-quality data packages.

Disclosure information not submitted.

Presentation(s):