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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
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192: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 2
Manage episode 508337804 series 3525243
Is continuous manufacturing delivering the transformative results everyone promised, or are you being sold an expensive solution to the wrong problem? While industry headlines tout revolutionary productivity gains, the economic reality behind continuous bioprocessing tells a more nuanced story that every process engineer needs to understand before making capital investment decisions.
In this episode, host David Brühlmann continues his conversation with Andreas Castan, Strategic Technology and Business Development Leader at Cytiva, diving deep into the hard economics and operational realities of next-generation manufacturing strategies. Andreas brings over 25 years of bioprocess expertise from upstream innovation to cGMP manufacturing scale-up.
Here are three critical takeaways from this conversation:
- Continuous vs Fed-Batch Economics Are Closer Than Expected: Andreas reveals real process economic modeling data showing that while continuous reduces capital costs through smaller bioreactors and facilities, higher media consumption (20-25% of COGS) and operational complexity often balance out the savings. The deciding factor isn't technology elegance but your specific production volume and pipeline needs.
- Regulatory Approval Isn't Easier Despite FDA Support: Even with regulatory enthusiasm for continuous processing, QA teams still demand the same fundamentals: traceability, batch definition, viral clearance validation, and process characterization. The technology choice should be driven by your business case, not regulatory preferences.
- Sustainability Benefits Are Modest: Contrary to industry hype, Andreas shares findings showing continuous manufacturing delivers only 20% carbon footprint reduction compared to optimized fed-batch. Real environmental gains come from HVAC efficiency and smaller cleanroom footprints, not inherent process advantages.
Ready to cut through the marketing noise and make data-driven manufacturing decisions? This conversation delivers the unvarnished truth about when continuous processing creates real value and when intensified fed-batch might be your smartest investment.
Connect with Andreas Castan:
LinkedIn: www.linkedin.com/in/andreas-castan-91570b1
Cytiva landing page: Process intensification
Online tool: Process intensifier
Next step:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
🧬 Stop second-guessing your CMC strategy. Our CMC strategy accelerator identifies critical roadmap gaps that could derail your timelines and gives you the clarity to build a submission package that regulators approve. Secure your spot at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-ready
194 episodes
Manage episode 508337804 series 3525243
Is continuous manufacturing delivering the transformative results everyone promised, or are you being sold an expensive solution to the wrong problem? While industry headlines tout revolutionary productivity gains, the economic reality behind continuous bioprocessing tells a more nuanced story that every process engineer needs to understand before making capital investment decisions.
In this episode, host David Brühlmann continues his conversation with Andreas Castan, Strategic Technology and Business Development Leader at Cytiva, diving deep into the hard economics and operational realities of next-generation manufacturing strategies. Andreas brings over 25 years of bioprocess expertise from upstream innovation to cGMP manufacturing scale-up.
Here are three critical takeaways from this conversation:
- Continuous vs Fed-Batch Economics Are Closer Than Expected: Andreas reveals real process economic modeling data showing that while continuous reduces capital costs through smaller bioreactors and facilities, higher media consumption (20-25% of COGS) and operational complexity often balance out the savings. The deciding factor isn't technology elegance but your specific production volume and pipeline needs.
- Regulatory Approval Isn't Easier Despite FDA Support: Even with regulatory enthusiasm for continuous processing, QA teams still demand the same fundamentals: traceability, batch definition, viral clearance validation, and process characterization. The technology choice should be driven by your business case, not regulatory preferences.
- Sustainability Benefits Are Modest: Contrary to industry hype, Andreas shares findings showing continuous manufacturing delivers only 20% carbon footprint reduction compared to optimized fed-batch. Real environmental gains come from HVAC efficiency and smaller cleanroom footprints, not inherent process advantages.
Ready to cut through the marketing noise and make data-driven manufacturing decisions? This conversation delivers the unvarnished truth about when continuous processing creates real value and when intensified fed-batch might be your smartest investment.
Connect with Andreas Castan:
LinkedIn: www.linkedin.com/in/andreas-castan-91570b1
Cytiva landing page: Process intensification
Online tool: Process intensifier
Next step:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
🧬 Stop second-guessing your CMC strategy. Our CMC strategy accelerator identifies critical roadmap gaps that could derail your timelines and gives you the clarity to build a submission package that regulators approve. Secure your spot at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-ready
194 episodes
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