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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

Send us a text

In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann dives into continuous bioprocessing - a major shift in biologics manufacturing that's turning traditional batch processes into streamlined, real-time operations.

Imagine running your biologics process non-stop for 30 days, with smart monitoring and smaller, more efficient systems replacing massive reactors. It’s not just possible - it’s already happening across the industry, from Amgen’s 80% smaller facility to Sanofi’s modular "Factory of the Future."

David explores how companies - big and small - are increasing productivity, cutting costs, and reducing waste through continuous strategies. You'll also hear about enabling technologies, phased implementation approaches, and the challenges teams are navigating as they make the shift.

Top 3 Takeaways:

• Efficiency & Cost Savings Are Real: Amgen’s results speak volumes: 80% smaller footprint, faster deployment, and cost reductions of over 60% per gram of protein.
• It’s Not Just for Big Pharma: Small and mid-sized biotechs are embracing continuous processes to stay competitive - gaining speed, flexibility, and lowering production costs without massive infrastructure.
• You Don’t Have to Go All In: Challenges like cost, complexity, and workforce readiness exist - but many companies are succeeding with hybrid models, applying continuous techniques step-by-step.

What’s your take on continuous manufacturing? Tune in, share your thoughts, and join the conversation about the future of biotech production.

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

Send us a text

In this episode, Tiago Matos, Associate Principal Scientist/Associate Director in Bioprocess Drug Substance and Commercialization at Merck & Co., shares a critical insight: continuous manufacturing in biologics currently demands 2–3x more time and FTEs than traditional fed-batch approaches. This highlights both the complexity of the shift - and the urgency for smarter digital tools and cross-functional collaboration.

With over a decade of experience and a strong track record in biologics and smart manufacturing, Tiago brings a balanced view of the promise and practical challenges of digital transformation in bioprocessing.

Top 3 Takeaways:

• Continuous Manufacturing is Coming - But Slowly: The infrastructure and tools aren’t fully ready. Progress depends on better-integrated solutions and stronger collaboration across industry, equipment providers, and regulators.
• Collaboration is Key: No one drives transformation alone. Digital, automation, modeling, and process experts must work together - like building a functional protein from diverse amino acids.
• Digital Twins and AI Will Bridge the Gap: AI, soft sensors, and digital twins will help streamline control strategies. The goal isn’t perfect models, but reliable, adaptive systems that improve in real time.

Tiago’s vision is both realistic and inspiring: the future of biologics manufacturing lies in openness, teamwork, and continuous learning.

What challenges or questions do you face in the shift to digital bioprocessing?

Here is what other guests had to say on this topic:

• Episodes 5-6: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov;
• Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli;
• Episodes 121-122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger.

Connect with Tiago Matos:

LinkedIn: www.linkedin.com/in/tiagobmatos

Merck & Co.: www.merck.com

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