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
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Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov - Part 2
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Biomanufacturing has always dealt with the challenge of turning vast, complex datasets and intricate production steps into life-changing therapies. But when batch records multiply and process deviations loom, how do biotech teams make sense of it all? In this episode, we move beyond theory to the nuts and bolts of how AI - when thoughtfully deployed - can turn bioprocessing chaos into actionable intelligence, paving the way for the factory of the future.
Our guest, Ilya Burkov, Global Head of Healthcare and Life Sciences Growth at Nebius AI, doesn’t just talk about data wrangling and algorithms—he’s spent years building tools and strategies to help scientists organize, contextualize, and leverage real-world datasets. Having worked across tech innovation and pharmaceuticals, Ilya Burkov bridges cutting-edge computation with the practical realities of CMC development and manufacturing, making him a trusted voice on how bioprocessing is rapidly changing.
Highlights from the episode:
- Advice for biotech scientists on learning from innovations in other industries (00:02:21)
- Tackling the complexities of organizing huge and often unstructured datasets in bioprocessing (03:08)
- Techniques and tools to structure, label, and prepare data for AI—including Nebius’s in-house tool, Tracto AI (06:24)
- Strategies for startups and small teams—how to begin implementing AI and what areas of bioprocessing to focus on first (10:12)
- The vision for the “factory of the future”: AI-driven, interconnected, and self-learning manufacturing environments (08:11)
- Navigating the decision between on-premise and cloud computing for scalable, cost-effective AI workloads (12:32)
- The importance of partnership between scientists and AI, emphasizing collaboration and data-driven decisions (00:15:47)
Wondering how to kick off your own AI-enabled bioprocessing project, or what to insource versus outsource as you scale? This episode gives you a grounded starting point—minus the buzzwords and empty promises.
Connect with Ilya Burkov:
LinkedIn: www.linkedin.com/in/ilyaburkov
Contact email: ilya.burkov@nebius.com
Nebius: www.nebius.com
If this topic grabbed you, you'll love these related episodes focusing on advanced modeling, continuous manufacturing, and Digital Twins
- Episodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari
- Episodes 85 - 86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli
- Episodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov
- Episode 153 - 154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos
- Episodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey
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