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
252: How to Use Media Supplements to Tailor Biosimilar Glycan Quality to Your Reference Product in Two Rounds
Use Left/Right to seek, Home/End to jump to start or end. Hold shift to jump forward or backward.
Are you still using one-factor-at-a-time experiments for biosimilar development, losing months, missing interactions, and risking costly dead-ends?
In this episode, David Brühlmann, host of the Smart Biotech Scientist Podcast, reveals how traditional "one factor at a time" screening in biosimilar development can take over 12 months, while the parallel group design massively accelerates discovery by grouping up to five factors per experiment and applying a multivariate analysis pipeline.
Topics discussed:
- The limitations of traditional and large DoE designs and the advantages of parallel group design (00:08)
- Best practices for grouping compounds by biological mechanism with four essential rules (00:53)
- The importance of anchor compounds, separating strong modulators, and initial univariate screens for unknown compounds (01:43)
- Guidance on managing practical issues, including evaporation, liquid handling, osmolality, and replicating production processes (06:42)
- The use of multivariate analysis tools: Principal Component Analysis, Mahalanobis distance, and decision trees for candidate selection (10:14)
- Key results and outcomes from applying the parallel group method, including faster and more cost-effective quality modulator identification (12:46)
- Three improvements David would recommend today: prequalifying compounds, broader quality analytics, and hybrid modeling integration (13:49)
- The shift in mindset from “time problem” to “information problem” in process development (16:50)
- Extending the parallel group and multivariate approach to other areas like clone selection and scale-up decisions (17:52)
Smart insight:
Process development is fundamentally about generating actionable information, not just running more experiments. The parallel group, multivariate pipeline lets teams ask better questions, in parallel, with dramatically improved data yield. This mindset and methodology extend well beyond biosimilar media development into clone selection, feed design, and process characterization, wherever complexity would paralyze traditional approaches.
If you want more detail, you can read the full article “Parallel experimental design and multivariate analysis provides efficient screening of cell culture media supplements to improve biosimilar product quality” published in Biotechnology and Bioengineering, which outlines the methods and findings behind this approach.
If you’re interested in hybrid modeling, here’s what previous podcast guests have shared on the topic, offering perspectives from fundamentals to real-world applications.
- Episodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov
- Episodes 99 - 100: From Raw Data to Actionable Insights: Unlocking the Power of Process Models with Fabian Feidl
- Episodes 137 - 138: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint
- Episodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey
Next step: If this was useful, leave a review on Apple Podcasts or Spotify. It helps other scientists find this content, and it genuinely matters.