Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
The go-to CMC and bioprocessing podcast for process development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics.
Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.
This podcast is for you if:
- You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership
- You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness
- You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny
- You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources
What you will learn:
CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling and manufacturing economics, continuous manufacturing and Industry 4.0 in biopharma, biologics modalities including mAbs, ADCs, and cell and gene therapies.
Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.
New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.
Next Steps:
Book a free assessment to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/assessment
Fast-track bioprocess development with expert guidance: https://bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
198: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 2
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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
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.