What happens when the most complex molecules in biotech meet the organizational challenge of managing 300+ analytical scientists? The answer lies not just in the science, but in building systems that turn technical complexity into reliable delivery.

In Part 2 of our deep dive with Amanda Hoertz, VP of Analytical and Formulation Sciences at KBI Biopharma, we shift focus from the molecular intricacies of ADCs to the operational mastery required to scale analytical development across multiple sites. Amanda reveals how her team achieves consistency across hundreds of scientists while maintaining the agility to pivot priorities in real time when critical programs need emergency support.

This isn't just about managing people; it's about architecting systems that preserve institutional knowledge, accelerate method transfer, and deliver results when regulatory deadlines loom.

What you'll discover:

• Seamless Project Handoffs Without Knowledge Loss: How KBI's stable team assignments eliminate the costly learning curves that plague most CDMO relationships, ensuring your molecule expertise stays with your program from development through commercial manufacturing.
• Organizational Scale Without Operational Chaos: The decision tree and layered reporting structure that allows 200+ analysts at a single site to function as a coordinated force, capable of rapid reprioritization and flood-level resource deployment when programs reach critical status.
• Digital Transformation That Actually Works: Beyond the automation buzzwords, Amanda walks through the practical realities of LIMS/ELN implementation, audit-compliant systems, and machine learning databases that transform raw data into defensible, actionable insights for complex biologics.

Whether you're evaluating how analytical capabilities scale with program complexity, or seeking practical insights into leading technical teams through digital transformation, this episode delivers the operational intelligence that separates successful ADC programs from expensive failures.

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

🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-round

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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

🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-round

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What if solving tomorrow’s bioprocessing challenges meant questioning the very physics of chromatography and reimagining downstream processing from the ground up?

For years, large biomolecules like viral vectors and exosomes have squeezed through the limitations of traditional chromatography, leaving scientists to wrestle with capacity trade-offs and slow mass transfer. But what if a fundamental shift could unlock breakthroughs for gene therapies, vaccines, and advanced biologics?

In this thought-provoking episode, host David Brühlmann sits down with Alois Jungbauer, professor emeritus of downstream processing at BOKU University (Vienna) and scientific advisor at BioChromatographix International. Together, they examine the future of chromatography and downstream processing, exploring innovations that tackle the challenges of modern gene therapy, advanced therapeutics, and sustainability in manufacturing.

Alois shares his perspective on anticipating industry needs, the importance of mentorship, and why the physical limits for purification of large biomolecules are yet to be reached.

Episode Highlights:

• The difference between solving current problems and anticipating the needs of the next generation in biotech (00:00)
• The promise and technical details of monolithic chromatography and its application for large modalities like gene therapy vectors and exosomes (03:01)
• Explanation of “inverted morphology" and AXISFLOW™ in new chromatography materials (03:18)
• Challenges and opportunities in continuous gene therapy vector production, and why it’s not widespread yet (07:40)
• The critical role of sustainability in downstream processing, particularly water usage and its impact on the viability and costs of distributed manufacturing (10:30)
• The relationship between reducing water consumption, manufacturing footprint, and cost of goods (12:16)
• Advice on scientific career development: listening, reading, understanding future industry needs, finding a mentor, and having persistence (13:50)
• Broader reflections on the value of science, societal perceptions, and science communication in today’s world (17:34)
• Alois’s key takeaway: downstream processing for gene therapy has not yet reached its physical limits—there is still significant room for improvement (20:26)

If you’re looking for fresh strategies to tackle the bottlenecks of large-molecule purification - and a candid perspective on where the real opportunities and societal responsibilities lie - you won’t want to miss this conversation.

Connect with Alois Jungbauer at leading conferences, including Bioprocessing Summit and Bioprocessing International, or find the next integrated continuous biomanufacturing event where he’s co-chairing.

Connect with Alois Jungbauer:

LinkedIn: www.linkedin.com/in/alois-jungbauer-14984811

Website : www.biochromatographix.com

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

Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at

🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-round

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