Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders 197: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 1
What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely?
Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to handle.
In this deep-dive episode, David Brühlmann sits down with Amanda Hoertz, Vice President of Analytical and Formulation Sciences at KBI Biopharma, where she oversees 300+ scientists across the mammalian network. Amanda's team has cracked the code on some of the industry's most challenging ADC programs, achieving a remarkable 93% batch success rate by rejecting cookie-cutter approaches in favor of molecule-specific development strategies.
What you'll discover:
- The Platform Fallacy: Why treating ADCs like standard monoclonals is costing companies millions and months of development time, and the bespoke analytical framework that's changing everything.
- Cytotoxic Payload Management: From free drug analysis to employee safety protocols, Amanda reveals the hidden complexities of handling molecules designed to kill cells, including the specialized facilities and analytical methods required for GMP manufacturing.
- Charge Heterogeneity Mastery: The analytical method that "keeps Amanda up at night," and the development strategies her team uses to achieve robust separation and qualification across multiple sites and analysts.
This episode delivers the technical depth and strategic insights that bioprocess engineers need to navigate ADC development successfully. Whether you're evaluating CDMO partnerships, optimizing analytical methods, or scaling complex conjugates, Amanda's proven strategies will transform your approach to these game-changing therapeutics.
Ready to master the analytical complexities that make or break ADC programs?
Connect with Amanda Hoertz:
LinkedIn: www.linkedin.com/in/amanda-hoertz-3aba605
KBI Biopharma: www.kbibiopharma.com
KBI Portal: www.standalone.kbi.bio
Next step:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.