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
214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari - Part 2
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Computational methods can predict stability issues before the lab. But how do you actually implement these approaches in your formulation workflow? From excipient selection to long-term stability prediction, in silico tools are transforming how biotech teams develop robust formulations while reducing costly trial-and-error cycles.
In Part 2, Giuseppe Licari, Principal Scientist in Computational Structural Biology at Merck KGaA, returns to share practical implementation strategies for integrating computational methods into biologics formulation development. Giuseppe reveals how molecular dynamics simulations guide excipient selection, where current methods hit their limits, and how emerging AI capabilities are expanding what's possible in formulation prediction.
Whether you're at a well-resourced pharma company or a lean startup, Giuseppe offers actionable guidance for leveraging computational tools to predict protein behavior, optimize formulations, and accelerate your development timeline.
Topics covered:
- Predicting protein aggregation and excipient interactions before manufacturing (00:45)
- Using molecular dynamics to understand protein behavior over time and in different environments (03:03)
- The interplay between computational predictions and experimental stability studies (04:49)
- The limitations of current in silico methods for predicting long-term stability (05:08)
- Emerging use of AI and machine learning to predict protein properties and improve developability (06:36)
- Future possibilities: Generative AI for protein design and formulation prediction (08:06)
- Advice for small companies: leveraging software-as-a-service and external partners to access computational tools (09:55)
- The impact of increasing computational power on the field's evolution (11:12)
- Most important takeaway: being open and curious about new computational techniques in biotech formulation (12:08)
Discover how to bridge computational predictions with experimental validation, navigate the current limitations of in silico stability forecasting, and position your organization to benefit from AI-driven formulation development, regardless of your resource constraints.
Connect with Giuseppe Licari to continue the conversation and explore how computational approaches can solve your formulation challenges before you ever step into the lab.
Connect with Giuseppe Licari:
LinkedIn: www.linkedin.com/in/giuseppe-licari
Next step:
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