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The world of biologics manufacturing is undergoing a major transformation. Once dominated by traditional batch processes, the industry is now experiencing a marked shift toward continuous bioprocessing.

But as companies contemplate this transition, two questions dominate strategic discussions: Will regulators accept continuous manufacturing? And, perhaps more pressingly, Does the business case justify making the switch?

In this podcast episode of the Smart Biotech Scientist Podcast, David Brühlmann dives into these pivotal topics - drawing insights from real-world case studies, regulatory updates, and economic analyses.

Top three takeaways:

• Regulators Are On Board: The FDA, EMA, and global agencies now actively support continuous processing when robust controls and monitoring are in place.
• Real Economic Wins: Cost of goods reductions of up to 35% are possible at certain production scales, with much smaller facilities and lower risk of batch failure.
• Hybrid & Phased Approaches Work: Companies are finding success by first investing in enabling technologies and gradually transitioning, rather than making sudden changes.

Continuous bioprocessing is no longer an experimental promise - it’s an evolving standard. With regulatory bodies championing the shift, real-world implementations proving technical and economic viability, and strong financial incentives for the right manufacturers, the transition becomes not a question of “if,” but “when.”

Curious how continuous manufacturing can fit into your strategy? Listen to this episode and share your thoughts or questions!

Next step:

Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call

Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech