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.
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 details to be announced
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.
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Meet with the KBI Biopharma Team:
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.
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.
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Celebrate 30 years of scientific collaboration at the WCBP Symposium on January 27-29, 2026, at the Mayflower Hotel in Washington D.C. WCBP stands for "well-characterized biotechnology product" and is known for its annual symposium focusing on the role of current and emerging CMC analytical technology within evolving US and international regulatory perspectives. The Symposium brings together industry, regulatory, and academic professionals to discuss these topics, with the theme for 2026 being "Integrating Science, Regulations, and Digitalization for Global Patient-Centered Care."