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Manufacturing & Analytical Characterization
Chalk Talk

Navigating the Biotherapeutic Commercialization Landscape

Monday, November 10, 2025
12:30 PM - 1:15 PM CT
Location:Spotlight Stage B, Aisle 2500, Exhibit Hall

Sponsored By 
Manufacturing and Analytical Characterization Partner Presentation-Manufacturing & Bioprocessing

    Chalk Talk Presenter(s)

  • Kelly Donovan

    Director
    KBI Biopharma
    Louisville, Colorado

Description: This presentation explores the evolving analytical strategies used in early and late phase characterization of biotherapeutics. Attendees will gain insights into phase-specific goals, regulatory requirements, and the distinct analytical approaches applied at each stage of development. By understanding the key differences between each phase, participants will be better equipped to align characterization strategies with development objectives and regulatory expectations to support successful commercialization.

Learning Objectives:

  • Differentiate the analytical goals and regulatory expectations between early and late phases of biotherapeutic development.
  • Identify key characterization methods and strategies used throughout the product lifecycle.
  • Recognize how phase-appropriate analytical strategies contribute to regulatory alignment and product quality throughout biotherapeutic development.