January 2026: WCBP (Well-Characterized Biopharmaceutical Product) Symposium by CASSS

Join KBI Biopharma at the WCBP Symposium 

Booth #29

When: January 27-29, 2026

Where: Mayflower Hotel, Washington, D.C. 

Schedule a meeting >>

Innovators Don't Gamble on Their Data...
They Come to KBI 

Your Program.  Faster.  Simpler.  Smarter.  No Surprises.

At KBI Biopharma, we know that successful drug development is fundamentally about reducing risk. Our analytical expertise gives you the visibility and data confidence you need to make informed decisions at every stage of development. Whether you're navigating IND submissions, scaling to commercial manufacturing, or solving complex analytical challenges, visit Booth #29 to see how we help.

TECH TALK: Regulatory-Ready Characterization:
From IND to BLA
Kelly Donovan, Director of Characterization Services

Tuesday, January 27 | 12:25pm – 1:25pm
Chinese Room 

Session Overview 

Don't gamble on your regulatory submissions. Gain critical insights into product characterization and regulatory expectations across the biotherapeutic development lifecycle. This session covers IND, IND amendment, and BLA submission requirements, illustrating best practices and highlighting how to identify potential risks before they jeopardize your path to market. 

Kelly Donovan is the Director of Characterization Services at KBI Biopharma's Louisville, Colorado site, where she leads a team specializing in biochemical separations, mass spectrometry, and biological characterization 

POSTER PRESENTATION: LC-MS Characterization of an Unexpected C-terminal HC Extension in a Therapeutic mAb 
Ben Zigterman, Sr. Scientist 

Poster details to be announced 

Poster Overview

Innovators don't gamble on their data. When standard methods missed a critical impurity, expert scientific insight and advanced LC-MS capabilities identified the issue before it became a costly late-stage failure, restoring product quality and consistency across manufacturing sites for successful BLA filing. 

At KBI, we believe the best outcomes happen when highly skilled scientists leverage cutting-edge analytical tools to solve complex challenges. Stop by to see what it looks like when deep expertise meets advanced technology, giving you the confidence to move forward without gambling on your program's success. 

View Full Conference Program Here >> 

Meet with the KBI Biopharma Team:

Schedule a meeting >>

Justin Smith​ 

Sr. Director, Marketing 

Kierra Banks, PhD ​

Director, Business Development, Analytical 

Kelly Donovan 

Director, Characterization Services ​

Jesse Coe, PhD  

Associate Director, Business Development, Analytical ​

Ben Zigterman 

Sr. Scientist, CCA  

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Why Stop by the KBI Booth? 

Data-Driven Confidence: World-class characterization services that de-risk your program by providing the analytical insights you need for regulatory submissions and commercial success. 

Risk Mitigation Strategies: Our team helps you identify and address potential challenges before they become costly setbacks, ensuring your program stays on track. 

Transparent Partnership: We provide the visibility you need into your product's critical quality attributes, empowering you to make strategic decisions with confidence. 

Proven Expertise: From early development through commercial manufacturing, our analytical capabilities reduce uncertainty across mammalian and microbial platforms.
 

Ready to see how we can de-risk your program? Stop by Booth #29 or schedule a one-on-one meeting with our team. 

 

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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: