The future of Pharma is Continuous: IMA at the forefront of innovation in OSD production.

IMA Active recently took part in a roundtable discussion, where five leaders from CONTINUUS Pharmaceuticals’ board of directors discuss why integrated continuous manufacturing (ICM) is the turning point for drug supply, cost, and speed, and how to scale it now.

Participants included Mark Bamforth, seasoned entrepreneur and CEO of U.S.-based CDMO Kincell Bio; Andrea Semprini Cesari, Director of Pharma Equipment at IMA Group; Alessandro Rollo, Managing Director of Change in Progress; Bill Marth, CEO of National Resilience and former CEO of Teva Americas; and Salvatore Mascia, Pharm.D., Ph.D., CONTINUUS Pharmaceuticals’ co-founder and CEO.

The conversation explores the limitations of traditional batch manufacturing, barriers to adoption of continuous processes, and what’s needed to unlock systemic change. Together, they lay out a bold vision for transforming drug manufacturing — from proof-of-concept to global implementation. Explore below the insights shaping the discussion:

David Alvaro (DA): To kick things off, can you each briefly introduce yourselves: your background, how your experience intersects with pharma manufacturing, and what first made you believe in CONTINUUS and its mission.

Mark Bamforth (MB): I’ve spent nearly 40 years in life sciences — 22 years with an innovator company managing global manufacturing operations and the past 15 years building and leading CDMOs. I’ve launched three CDMOs and currently run a fourth, while also supporting several others through investments and mentorship of their CEOs.

I first encountered CONTINUUS when the team was still at MIT, working under the Novartis-sponsored initiative. I stayed loosely connected until early 2019, when Sal and I reconnected. That conversation re-energized my interest, and I soon invested and joined the board. What they’re doing is truly groundbreaking.

Andrea Semprini Cesari (ASC): I’ve been with IMA for over 30 years, currently leading our pharma process equipment division. IMA has supported CONTINUUS since the very beginning, around 2013. I’ve served on the board for nearly a decade because we recognized early on that this technology could truly define the future of pharma manufacturing.

Alessandro Rollo (AR): I’m an investment banker and fund manager focused on industrial innovation. My fund, Change in Progress, targets later-stage companies transforming industrial processes — a key interest of mine. I’ve known Sal for nearly 20 years and invested in CONTINUUS from day one. Earlier this year, I joined the board and am eager to help scale the company’s impact.

Bill Marth (BM): I’m a pharmacist with an MBA in finance. After early roles at Bristol Myers Squibb, I joined Teva when it was a $1B company and rose to CEO of Teva U.S. and later CEO of the Americas, managing $12 billion in business. I later led Albany Molecular Research until its $1.65 billion sale in 2017. Today, I lead National Resilience, a U.S.-based CDMO backed by ARCH Ventures and 8VC. I joined CONTINUUS’s board 16–18 months ago after Mark reached out. The innovation here keeps me excited.

Salvatore Mascia (SM): I’m a pharmacist and chemical engineer by training. I joined the Novartis-MIT Center for Continuous Manufacturing in 2008 and eventually led the team that built the first end-to-end continuous manufacturing system. I saw early on that the technology’s full impact required more than academic proof—it needed commercialization. That insight led me to co-found CONTINUUS Pharmaceuticals with key shareholders to bring end-to-end continuous processes into the pharma mainstream.

I’m incredibly grateful to be supported by this remarkable board. Each of these individuals brings unique strengths and a shared commitment to transforming the industry.

DA: Offshoring of active pharmaceutical ingredients (APIs) and key starting materials (KSMs) has long been a vulnerability in pharma, but it now feels more urgent and complex. Why has reshoring been so difficult in the U.S. and Europe, and are we finally reaching a turning point? What structural shifts might drive real change?

MB: Pharma manufacturing became commoditized over time, driving production of small molecules to lower-cost regions like India and China. In contrast, biologics are harder to relocate since the processes are typically more complex and the facilities are approved along with the product, making it harder to transfer manufacturing after product approval.

COVID was a major wake-up call: countries without internal manufacturing capacity risked being cut off from supply. The United States locked up a significant share of domestic production, and interest in onshoring was already building. Today, with rising supply chain complexity and the need for supply security, reshoring has become a strategic priority. Continuous manufacturing offers what is likely to be a key component of the solution to cost-effective and flexible manufacturing.

BM: We’ve seen a bifurcated strategy: branded pharma followed favorable tax environments, while generics chased the lowest cost, often ending up in India or China. APIs are still heavily dependent on China for key starting materials. At Albany Molecular, we sourced all KSMs from China, even when we had our own facilities in India.

But our branded partners wouldn’t allow us to manufacture in India, so we invested in Spain and Italy instead. Now, post-COVID, there’s strong momentum toward reshoring, but even if APIs are made in the U.S., reliance on offshore KSMs remains a vulnerability.

At National Resilience, we’ve worked closely with the current administration. They’re committed to rebuilding domestic capacity—but they also understand the complexity of the task.

MB: That’s a great point. Many companies moved manufacturing to Ireland or Switzerland, not for cheap labor but for tax reasons. Tariffs are just another form of tax. If we want to reverse that trend, tax policy needs to be part of the reshoring solution.

BM: I recently told Sal that another private equity group and I acquired 13 CDMO sites in Europe for $113 million. We just sold one of those sites to the Swedish government for $75 million. Why? They want to bring antibiotic manufacturing back to the Nordics. So yes, reshoring is no longer merely theoretical –– it’s already happening.

ASC: Pharma is facing both structural and cyclical pressure, leading companies to rethink traditional business models. Reshoring is part of that, but it’s expensive and will take time. That’s why continuous manufacturing is so important. It can accelerate the shift, reduce dependence on China and India, and increase resilience. The U.S. government is actively looking for these kinds of solutions. This is a pivotal moment — and also a unique opportunity.

DA: As reshoring gains attention, conventional batch manufacturing seems increasingly misaligned with today’s complex, personalized, and costly therapies. What limitations does the batch model pose, especially for reshoring, and what challenges remain in getting the industry to adopt a fundamentally new approach like continuous manufacturing?

MB: One core challenge is pricing. In the United States, prices are set by private payers; in Europe, it’s government-run systems. That creates fragmentation and makes it hard to align incentives for reshoring. If we want to bring manufacturing back, we need to lead with innovation. Smaller, more efficient systems that reduce reliance on large, labor-intensive plants are the way forward for many products. That’s where technology becomes a real enabler.

SM: Traditional batch manufacturing depends on massive, fixed-footprint plants with high capital and operational costs: facilities that don’t move easily when tax policies or regulations change. What we need is a permanent, flexible solution.

Continuous manufacturing enables that by shrinking the footprint, reducing CAPEX, and consolidating multiple steps into a single, integrated process. That allows for localized, cost-effective, and sustainable production. This is the path to reshoring that actually makes sense, and CONTINUUS is well-positioned to deliver it.

BM: We also have to stay realistic about who this is for. We’ve tried applying this model to generics, and it just doesn’t work at their price points. Our sweet spot is branded pharma, where the value proposition includes capital savings, operational efficiency, and risk reduction.

We may not be the cheapest option on a per-dose basis, but we can eliminate labor, cut capital outlays — say $50 million versus the $200 million needed for a traditional facility — and offer speed and flexibility. That’s where CONTINUUS stands out, and it’s important we stay focused on those segments where we can create the most impact.

DA: CONTINUUS has redefined continuous manufacturing beyond traditional flow chemistry and modular units. Are potential partners open to this more integrated vision, or is it still a challenge to shift industry thinking?

MB: Pharma is a conservative industry. Once a product is approved, companies are hesitant to change the manufacturing process unless it solves a supply problem, especially given regulatory constraints and the lengthy process for regulatory approvals. That mindset is less rigid for small molecules than biologics, but it’s still pervasive.

A useful comparison is single-use bioreactors. They were in use for years for clinical supply before hitting a tipping point around 2010. Now, they’re standard for clinical and commercial supply of smaller-scale biologics because they reduce setup time and cost while enabling decisions closer to execution. I see continuous manufacturing following a similar path.

What CONTINUUS offers is full end-to-end integration, not just improvement of a single step. That makes the system faster, more flexible, and more responsive to demand. Often, the real value lies in that responsiveness, not just lower cost of goods.

ASC: This isn’t just a technological upgrade — it’s a fundamental shift in how pharma manufacturing is conceived and executed.

The industry faces three major challenges: building supply chain resilience, reducing costs without compromising quality, and capitalizing on reshoring opportunities. Continuous manufacturing addresses all of them. But it requires more than just installing new equipment; it demands a rethinking of processes, skill sets, and even the surrounding ecosystem. Unless companies treat it as a revolution, not a tweak, adoption will remain limited.

SM: I couldn’t agree more. When people hear “continuous manufacturing,” they often think “flow chemistry,” but that’s not what we do. If it were, CONTINUUS wouldn’t need to exist.

What sets us apart is full integration with new technologies. By unifying every step of production into a single system, we unlock speed, precision, and cost reduction. The transformation happens at the system level.

I also want to revisit something Bill raised earlier about generics versus branded pharma. We looked closely at Metformin — a high-volume, low-cost generic. We showed clear operational benefits using continuous manufacturing: fewer staff, better yield, improved quality. But the CAPEX was the dealbreaker. Building a state-of-the-art continuous facility would cost about $50 million, which just doesn’t work for a product that sells for a few dollars per kilogram.

That raises a policy question: could the U.S. government support advanced facilities for essential generics as part of its reshoring push? We could imagine public investment to make this innovation accessible.

BM: It’s a good idea, but I’m not optimistic. I don’t see large-scale generics like Metformin coming back to the U.S. — the economics just don’t work. Even if we solve the manufacturing cost, reimbursement remains a problem. How do you convince payers to spend more on a product they’re used to getting for pennies?

That’s why I believe CONTINUUS should stay focused on branded pharma. Disease areas are becoming smaller and more targeted, and the manufacturing is more complex. That’s where our model adds real value.

MB: The real power of continuous manufacturing isn’t just about reshoring. It’s about solving critical challenges in pharma manufacturing, particularly for complex, resource-intensive processes.

Traditional batch systems are slow, inefficient, and infrastructure-heavy. Continuous processes compress lengthy timelines and reduce validation, quality testing, and downtime. That agility is invaluable for early-phase development and programs that need rapid scale-up.

CONTINUUS isn’t just optimizing one part of the process; it’s redefining the whole system. That enables faster, more responsive manufacturing with a smaller environmental footprint. That’s what gets big pharma’s attention: not just cost, but flexibility, speed, and adaptability.

BM: Imagine taking a 135-step synthesis and shrinking it to 20 steps, all executed seamlessly in one system. That’s the scale of transformation we’re talking about.

MB: And completing it in two days instead of two months.

BM: That’s the game-changer.

MB: And with real-time monitoring and built-in quality control, you’re embedding assurance into the process, not bolting it on afterward.

SM: That’s the power of full integration: speed, precision, and reliability in one.

DA: Continuous manufacturing represents a true paradigm shift, but high CAPEX and industry inertia remain major barriers. Beyond government incentives, are there innovative models — like co-investment or regulatory partnerships — being explored to help de-risk adoption and accelerate uptake?

BM: It depends on the application, but there’s momentum. Billions of dollars have already been mobilized, particularly through reshoring initiatives that began under the Trump Administration.

Take peptides, for example. Much of the current supply chain is anchored in China, where fragments are synthesized and shipped to the United States for final assembly. It’s solvent-intensive and environmentally unsustainable. Now imagine deploying a CONTINUUS machine in the United States to produce peptides end-to-end, cleanly and efficiently. That’s the kind of targeted, high-impact solution that attracts both government support and private capital because it solves a real, urgent need.

ASC: I believe that the U.S. government is serious about reshoring. But it won’t happen without public-sector support. Manufacturing costs in the U.S. are simply too high compared with China, India, or Southeast Asia. Without meaningful economic facilitation — grants, incentives, or infrastructure support — reshoring will be slow and limited. Tariffs alone won’t drive the systemic change required –– there must be a larger strategic plan.

MB: I agree. Big Pharma has already committed around $150 billion to build facilities in the United States. So why haven’t they adopted continuous manufacturing at scale? Because they want proof.

If CONTINUUS had a GMP-compliant facility up and running — producing phase I materials and demonstrating benefits like shorter lead times and improved supply chain control — it would be a game-changer. That proof point would validate the model, give investors confidence, and unlock public and private funding for broader adoption.

We’ve done the engineering. We’ve shown the potential. What’s missing is a fully operational, clinical-ready facility that proves the system works in real-world settings. That’s the next big step and the key to accelerating uptake.

DA: Looking ahead three to five years, what needs to happen to drive broader adoption of CONTINUUS’s model? Is it about landing a high-profile proof of concept, validation from a major partner, or a steady build of incremental wins? What does success look like to you?

MB: Our immediate goal is to launch a GMP-compliant facility capable of manufacturing clinical trial materials. That’s the first milestone toward embedding our technology in real programs. Longer term, success looks like building a commercial manufacturing facility in partnership with a large pharma company. That would be the definitive proof point for our model.

But regardless of the timeline, the pathway is clear: start with clinical material, move through the development pipeline, and ultimately demonstrate commercial-scale success. Small molecules are our starting point, but we see applications across multiple modalities.

BM: It all starts with solving one real problem. Once we have a case where the technology delivers real value, we’ll have a tangible example others can rally around. People need to see it working in the real world. That’s what unlocks broader interest.

SM: We’re very close. We’re currently making plans with a top-tier pharmaceutical partner to build our first commercial GMP facility, expecting a final decision in 2025. That’s a huge step.

But we also recognize the need to support earlier development stages. That’s why we’re planning to raise capital this year to upgrade one of our current facilities so we can produce phase I material in-house. With both a commercial demonstration underway and early-phase capability, we’ll have the infrastructure to support programs across the development continuum.

MB: To add to that, CONTINUUS has already shown it can solve targeted challenges, often addressing specific unit operations in pharma processes. Now we’re shifting from one-off fixes to fully integrated solutions. We’re helping pharma partners see that the value isn’t just in removing bottlenecks; it’s in transforming the entire manufacturing workflow.

When companies experience the benefits of that end-to-end integration — faster timelines, better control, more flexibility — that’s when adoption really accelerates.

DA: Have you found that experiencing you help them to solve a specific challenge — say, a single unit operation — makes companies more open to adopting a fully integrated continuous solution? Or is there still a significant barrier between early engagement and full-scale adoption?

MB: We’ve seen one compelling example: a company we helped resolve a specific supply issue for is now considering a commercial implementation. What we need is that first commercial proof point.

AR: This is where industrial policy can make a real difference. We’ve seen the U.S. government invest directly in strategic supply chains, like the Department of Defense taking a 15% stake in a rare earth processing company to ensure domestic access. The same logic applies to pharmaceuticals.

With global instability and increasing supply chain risks, we should treat access to essential medicines as a national priority. Government action — whether through equity investments, co-development models, or other incentives — could play a pivotal role in accelerating the adoption of technologies like continuous manufacturing. If the private sector doesn’t move fast enough, public intervention may be the key to closing the gap.

DA: While we’ve focused mostly on the U.S., are there other regions — especially those trying to catch up to major pharma hubs — where the environment might be more favorable for adopting disruptive technologies like continuous manufacturing? Is CONTINUUS actively pursuing opportunities beyond the United States and Europe?

SM: We’re not limiting ourselves geographically. While much of the reshoring conversation is centered in the U.S., CONTINUUS has always taken a global view. Our focus is solving real manufacturing problems, wherever they arise. We’ve worked with clients in the U.S., Europe, and India, and some of our most advanced discussions to date have been with European companies. One potential commercial plant could even be located farther east. We approach this with a 360-degree mindset: identify the need, demonstrate the value, and then determine how best to deploy our platform.

ASC: To my knowledge, there aren’t yet any national or regional initiatives in Europe or elsewhere that actively promote the shift from batch to continuous manufacturing. It’s still driven by individual companies. There are no structured incentives or programs — certainly not in Italy or across the broader EU — that will make this transition easier. However, that also creates a significant opportunity for CONTINUUS. When we speak with pharma companies, there’s clear interest in continuous manufacturing — but also a major knowledge gap.

Many companies want to explore the model but don’t fully understand how to implement it or what it requires. That’s where CONTINUUS can play a vital role, not just as a technology provider but as a strategic partner, a consultant, and potentially even a CDMO. We’re well-positioned to bridge that gap and become the trusted guide for companies navigating this transformation.

DA: As we wrap up, are there specific risks or opportunities that stand out to you personally — something that keeps you up at night or excites you most? And what’s your call to action for CONTINUUS or for the broader pharma ecosystem?

MB: I think that we’re aligned with Sal’s vision. But if I reflect on the journey, we’ve made some big bets: first with a generic facility, then a U.S. supply initiative, and now a major pharma partnership. These are ambitious efforts, but they’ve taken years to develop, and they’re not guaranteed.

The core challenge remains: What is the repeatable solution we can offer? What’s the compelling product that solves an urgent problem for multiple companies, not just one? That’s still the opportunity we’re working to define. My call to action is for us to keep sharpening that focus, while also looking beyond small molecules. Where else could this platform make a difference? And who’s ready to support that vision — through investment, non-dilutive funding, or strategic partnerships?

SM: For me, the two big hurdles are the long development timelines and the high upfront CAPEX. Continuous manufacturing requires co-developing the process and the equipment, which takes time, and that’s a deterrent. We’ve seen promising projects stall because companies hesitate at the starting line. If we can reduce the time and cost to get to proof of concept, I believe adoption will accelerate. As for a call to action, mine is directed inward. We can’t wait for policy to solve this. We have to deliver the GMP proof of concept in small molecules. That’s the milestone everything else hinges on. But we also need to think about what comes next: What’s CONTINUUS 2.0? Once we’ve validated the model, how do we evolve it and expand into new modalities? That’s where the real impact lies. We shape that future ourselves.