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.
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Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
213: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari - Part 1
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What if you could predict formulation failures before ever touching a pipette? Computational approaches are revolutionizing biologics development, replacing trial-and-error experimentation with predictive intelligence that catches stability issues early and accelerates your path from candidate selection to clinic.
In this episode, David Brühlmann welcomes Giuseppe Licari, Principal Scientist in Computational Structural Biology at Merck KGaA. A chemist by training, Giuseppe transitioned from wet lab experimentation to the predictive power of in silico modeling. Today, he operates at the intersection of computational biology and CMC development, using digital tools to screen candidates for developability, predict formulation challenges, and de-risk development programs before committing resources to the lab.
Discover how computational methods are transforming the way biotech companies approach developability assessment and formulation strategy:
- Why maximizing shelf life isn’t always necessary in early development phases (02:56)
- The critical role of communication between computational and bench scientists (06:46)
- Core properties to assess for developability, including hydrophobicity, aggregation, charge, and immunogenicity (11:06)
- How accurate are in silico predictions, and where do they add the most value? (13:23)
- The limitations and strengths of machine learning and physics-based models in predicting protein behavior (15:19)
- The differences between developability, formulation development, and formulatability, and the value of early cross-functional collaboration (17:17)
- When to use platform formulations and when tailored approaches are needed for complex molecules (19:25)
- The advantages of using computational methods at any stage, especially for de-risking strategies (20:13)
Listen in for practical strategies for integrating in silico predictions into your developability and CMC workflows, catching stability issues before the lab, and making smarter development decisions that save time, material, and money.
Connect with Giuseppe Licari:
LinkedIn: www.linkedin.com/in/giuseppe-licari
Next step:
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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.