Continuous manufacturing is no longer a futuristic concept. It's here, and it's rewriting the rules of biologics production. For years, with a few exceptions, biopharma has relied on traditional fed-batch processes that, while reliable, come with bottlenecks, downtime, and limitations. But what if we could do better? What if we could make biologics production as seamless, efficient, and intelligent as the technology driving it?

This article will explore how continuous manufacturing is revolutionizing the biotech industry. From real-world case studies to enabling technologies and economic insights, I will explain the rise of constant bioprocessing and what it means for your lab, facility, and future.

This concept is discussed in greater detail in an episode of the Smart Biotech Scientist Podcast, hosted by David Brühlmann, founder of Brühlmann Consulting.

The Rise of Continuous Manufacturing in Biotech

If you've worked in process development or manufacturing, you've likely experienced the limitations of batch processing: large equipment, long turnaround times, and variable outcomes. Continuous manufacturing flips that model. By designing a flowing system, we can eliminate inefficiencies and elevate consistency.

In 2023, the continuous bioprocessing market stood at $218 million. By 2028, it's projected to reach $599 million. That's a 22.4% compound annual growth rate. 

Why the surge? Because the benefits are too significant to ignore:

• Higher productivity and volumetric efficiency
• Reduced capital and operational costs
• Smaller facility footprints
• Enhanced product quality and consistency
• Greater agility and speed to market

From perfusion cell culture to continuous downstream purification and integrated end-to-end systems, biotech companies are rethinking how they manufacture therapies—and it's working.

Enabling Technologies Powering the Shift

This evolution wouldn't be possible without significant advances in bioprocess technology. Enabling technologies, such as single-use bioreactors, automation, and advanced analytics, have become foundational for continuous systems.

Key innovations include:

• Single-Use Systems: Flexible, modular setups that reduce cleaning, setup, and turnaround time
• Process Analytical Technology (PAT): Real-time process monitoring and feedback control loops that keep operations on track
• Advanced Chromatography Systems: Techniques like simulated moving bed (SMB) and periodic countercurrent chromatography (PCC) increase resin efficiency and reduce buffer use
• Continuous Filtration: Single-pass tangential flow filtration (SPTFF) and alternating tangential flow (ATF) help maintain steady upstream flow and downstream separation

These tools work together to enable smooth, high-density, high-quality runs, backed by data visibility and system responsiveness.

Real-World Success Stories

Let's look at a few industry leaders embracing continuous bioprocessing:

Amgen's Singapore Facility

Amgen built a continuous manufacturing facility in Singapore that slashed its footprint by 80% and operating costs by 60%. Its flexible, modular design relies on single-use systems, real-time analytics, and integrated purification. It's not just efficient; it's fast, with construction completed in half the time of a conventional plant.

Sanofi's Framingham Site

Sanofi launched a fully digitized, continuous manufacturing plant that reduced chemical use by 94% and water by 91%. The flexible plant setup enables rapid changeovers and significant reductions in environmental impact. With uptime at 99%, it's a lean, green biotech case study.

Transcenta Holdings

Transcenta developed a fully integrated continuous bioprocessing (ICB) platform. Their perfusion systems reach cell densities of over 100 million cells/mL, while their end-to-end control systems deliver consistent quality. They replaced massive stainless-steel reactors with a handful of 1000L single-use bioreactors, providing 10 times the output.

Tackling the Challenges

Despite its benefits, continuous biomanufacturing isn't without hurdles. Misconceptions and technical barriers continue to hinder adoption.

Common concerns include:

• It's too complex or costly to implement
• It's not suitable for large-scale production
• Regulators won't accept it
• It only works for specific molecules

But these are being addressed head-on.

Recent regulatory support has been encouraging. The FDA, EMA, and ICH have all released guidance or legislation that supports continuous bioprocessing, including ICH Q13 and Q9(R1). Meanwhile, biotechs invest in workforce training, automation, and digital infrastructure to close capability gaps.

Strategic Implementation: A Phased Approach

For companies interested in transitioning, a phased implementation is often the most effective approach.

Start small by targeting one or two unit operations where continuous technology is mature:

• Use perfusion in the seed expansion N-1 step) or in the production stage
• Implement multicolumn chromatography for continuous capture or polishing

From there, build toward integrated continuous platforms. Monitor performance, validate success, and scale gradually. With this measured approach, even small and mid-sized biotechs can see gains without overhauling their operations overnight.

Economic Insights and Business Case

Continuous manufacturing isn't just a technical upgrade; it's a strategic shift.

Studies from UCL and MedImmune show that continuous setups:

• Reduce COGs by 20–35% at commercial scale
• Cut capital expenditures by up to 50%
• Increase productivity 4–5x
• Enable smaller, more efficient facilities

The cost of goods savings are particularly striking; around 35% for production volumes in the 100–500 kg range, and still over 10% at larger commercial scales. While the upfront costs for tech and training may be higher, the long-term returns are hard to ignore. Hybrid facilities that combine batch and continuous elements allow flexible scaling and gradual transformation.

Regulatory Support is Growing

Gone are the days when regulatory uncertainty blocked innovation. Agencies like the FDA and EMA now actively support continuous biomanufacturing.

• The FDA's Quality Considerations for Continuous Manufacturing guidance outlines clear expectations for real-time monitoring and process validation.
• ICH Q13 (2023) sets out a global framework for both drug substance and drug product manufacturing
• ICH Q9(R1) (2025) updates risk management principles to support continuous systems

This regulatory clarity removes a significant barrier and opens the door for broader adoption.

Final Remarks

The shift to continuous biomanufacturing is happening fast. With cost savings, improved product quality, and stronger regulatory support, the case for constant processing has never been stronger.

If you're considering a move, begin with an honest assessment of your current operations. Identify where continuous technologies can offer the most significant return on investment (ROI). Talk to vendors. Build internal support. And take the first step.

Continuous processing isn't just for the giants. It's for biotech teams who want to do more with less, move faster, and stay competitive in a rapidly evolving landscape.

If you're ready to explore your options, book a free consultation with our team at https://bruehlmann-consulting.com/call

The future of biotech manufacturing isn't batch by batch. It's continuous.

David Brühlmann is a strategic advisor who helps C-level biotech leaders reduce development and manufacturing costs to make life-saving therapies accessible to more patients worldwide.

He is also a biotech technology innovation coach, technology transfer leader, and host of the Smart Biotech Scientist podcast—the go-to podcast for biotech scientists who want to master biopharma CMC development and biomanufacturing.  

Hear It From The Horse’s Mouth

Want to listen to the full interview? Go to Smart Biotech Scientist Podcast. 

Want to hear more? Do visit the podcast page and check out other episodes. 
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