Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders 205: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 1
Your Manufacturing Decisions Are Costing You More Than You Think
Every bioreactor decision. Every scale-up choice. Every facility investment. They're all silently writing checks your process might not be able to cash.
The difference between a profitable biologics program and one that bleeds capital? Process economic modeling, the analytical framework that reveals exactly where your money goes and why.
In this episode of the Smart Biotech Scientist Podcast, David Brühlmann talks with Niklas Jungnelius, Process Modeling Leader at Cytiva, who has spent 25+ years decoding the economics of biologics manufacturing for biotech companies navigating billion-dollar decisions.
Niklas reveals the hidden cost drivers most teams miss, the surprising economics behind fed-batch vs. continuous processing, and why your facility choice at intermediate scale could make or break your business case.
Episode Highlights:
- What process economic modeling is and how it differs from mechanistic modeling (06:40)
- Main cost drivers in biologics and biosimilars manufacturing, and their direct and indirect impacts on patient pricing (09:21)
- The role of manufacturing scale and productivity in driving down costs, and how facility type (stainless steel vs single-use) affects labor, flexibility, and investment (11:51)
- Trade-offs between single-use and stainless steel facilities at intermediate production scales (15:07)
- Key differences in cost and efficiency between fed-batch and fully continuous manufacturing, including productivity limitations and capital/expenditure implications (16:20)
- The impact of resin lifetime and under-utilization on clinical manufacturing costs (19:51)
- Hidden or less quantifiable costs such as facility flexibility, excess capacity, safety margins, and the importance of realistic assumptions in economic modeling (20:20)
This is a grounded discussion with practical takeaways for biotech scientists seeking clarity in the complex terrain of process economics. Part two of this conversation will focus on sustainability modeling and the latest technologies reshaping bioprocessing economics.
Ready to see how process modeling could transform your approach and protect your bottom line? Listen to the episode and rethink your next investment.
Connect with Niklas Jungnelius:
LinkedIn: www.linkedin.com/in/niklas-jungnelius
Cytiva website: www.cytivalifesciences.com/en/us
Next step:
Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-founders
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
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.