KBI Biopharma
Deanna Hunt
Senior Director, Business Development
Join KBI Biopharma at AAPS
When: November 9-12, 2025
Where: San Antonio, TX
KBI Biopharma is headed to San Antonio for AAPS this November!
Schedule a meeting >>
Meet with the KBI Biopharma Team:
Kelly Donovan
Director, Characterization Services
Jesse Coe
Associate Director, Business Development,PhD
LIVE TALK: Navigating the Biotherapeutic Commercialization Landscape
Kelly Donovan, Director of Characterization Services
Monday, November 10 | 12:30pm – 1:15pm
Spotlight Stage B, Aisle 2500, Exhibit Hall
Session overview
Gain critical insights into product characterization and regulatory expectations across the biotherapeutic development lifecycle. This session covers IND, IND amendment, and BLA submission requirements, featuring an ADC case study that illustrates best practices and highlights potential risks in bringing biotherapeutics to market.
Key topics:
- Product characterization overview
- Regulatory expectations for IND, IND amendments, and BLA submissions
- ADC case study
- Best practices and risk mitigation strategies
About the Speaker
Kelly Donovan is Director of Characterization Services at KBI Biopharma's Louisville, Colorado site, where she leads a team of scientists specializing in biochemical separations, mass spectrometry, and biological characterization. With over 20 years of experience in biotherapeutic product characterization, Kelly's expertise centers on the Elucidation of Structure section of Marketing Applications, a critical component of regulatory submissions.
View Full Conference Program Here >>
About KBI Biopharma:
KBI Biopharma is a leading global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of our 1400+ client partners, we work closely to personalize and accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, we deliver robust process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs. Recognized for quality manufacturing, we help clients advance drug candidates into the clinic and beyond.
Learn more about KBI Biopharma >>
About the Event:
AAPS is the convener of the pharmaceutical science community, bringing together thousands of scientists from across the world and the drug development process.
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