Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.
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, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.
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:
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
215: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov - Part 1
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Across biotech labs, researchers swim in oceans of process data: sensor streams, run records, engineering logs, and still, crucial decisions get stuck in spreadsheets or scribbled into fading notebooks. The challenge isn’t having enough information, it's knowing which actions actually move the needle in cell culture productivity, process stability, and faster timelines.
This episode, David Brühlmann brings on Ilya Burkov, Global Head of Healthcare and Life Sciences Growth at Nebius AI. With a career spanning NHS medicine, regenerative research, and cloud infrastructure, Ilya Burkov has lived the leap from microscope to server room. He’s seen firsthand how digital twins, autonomous experimentation, and cloud-first strategies are shifting the way biologics are developed and scaled.
Topics discussed:
- Shifting from experimental-based to computational bioprocess development, and the evolving role of human expertise vs. AI (02:48)
- Ilya Burkov's journey from medicine and orthopedics to AI and cloud infrastructure (04:15)
- Solving data silos and making real-time decisions with digital twins and automated analytics (06:36)
- The impact of AI-driven lab automation and robotics on drug discovery timelines (08:51)
- Using AI to accelerate cell line selection, cloning, and protein sequence optimization (10:12)
- Why wet lab experimentation is still essential, and how predictive modelling can reduce failure rates (11:15)
- Reducing costs and accelerating development by leveraging AI in process screening and optimization (12:32)
- Strategies for smaller companies to effectively store and manage bioprocess data, including practical advice on cloud adoption and security (14:30)
- Application of AI and digital twins in scale-up processes, and connecting diverse data types like CFD simulations and process data (17:18)
- The ongoing need for human expertise in interpreting and qualifying data, even as machine learning advances (19:09)
Wondering how to stop your own data from gathering dust? This episode unpacks practical strategies for storing and leveraging your experimental records - whether you’re in a major pharma or a small startup with limited tech resources.
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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