Going Against the Grain: Why Cell Therapy Needs a Different Kind of CDMO

Our Chairman and CEO, Syed T. Husain, recently sat down with PharmaBoardroom to talk about where cell therapy manufacturing is headed and the role Made Scientific plans to play in getting it there. He shares the story of our transformation from BioCentriq, why we chose to focus solely on cell therapy, how we build partnerships around the real ups and downs of clinical trials, and how we're scaling capacity to grow alongside the field. We're grateful to PharmaBoardroom for the conversation and excited to share it with you here.

Could you walk us through your journey of transforming BioCentriq into what is now Made Scientific?

I was introduced to cell therapy during my previous role at Resilience and came away seeing it as an exciting space that was clearly ripe for disruption. Everyone talked about the disruption happening on the scientific and technical side, but almost no one was talking about the disruption needed on the CDMO side specifically. When this opportunity came along in 2024, the company was still BioCentriq. It was a cell and gene therapy-focused CDMO founded out of NJIT here in New Jersey, small in scale, and still had an academic mindset. What the industry actually needs from a cell therapy CDMO is focus and scalability, and I saw the foundational pieces already in place here.

What tipped it for me was our parent company, GC Corporation. GC is a multi-billion-dollar South Korean healthcare company approaching its 60th year and has a long-standing passion for cell therapy. In fact, one of their own portfolio companies has already commercialized a cell therapy product. They had acquired BioCentriq because they believed in the value of strategically backing a cell therapy-focused CDMO capable of reshaping the industry. Between that backing and the foundation already in place, it felt like the right moment to make the move from Resilience and build something new. 
 

What was wrong with the existing cell therapy CDMO model, and what does Made Scientific represent that BioCentriq did not?

In my view, most CDMOs in this space remain stuck in a fairly academic mindset and are run by scientists who operate at lab scale. To me, the market need was clear. There simply were not cell therapy-focused CDMOs consistently delivering, and innovators were struggling as a result. It was a genuine opportunity to reset the business entirely, infrastructure, people, processes and systems, and having a strategic backer made that possible. 

A complete rebuild of a company takes real financial patience and a strategy that isn’t weighed down by legacy issues. We also made the decision early on to focus solely on cell therapy. The complexity there is significant enough on its own without diluting focus across multiple modalities. So from the moment I joined in Q4 2024, we became a dedicated cell therapy CDMO and immediately began resetting the strategy from the ground up. By early 2025, Made Scientific was born. “Made” stands for Manufacturing and Development Excellence, and we are built specifically to deliver what other CDMOs hadn’t before: the right infrastructure, people focused purely on execution, and the financial backing to build it properly. 

We acquired our facility here in Princeton as our new headquarters, which spans 60,000 square feet of manufacturing space. Rather than rush straight into signing contracts, we then invested roughly 15 million USD upfront to make sure the facility was built out for clinical-to-commercial work, and FDA and EMA-ready from day one. As we are not private equity backed, decisions here are not shaped by short-term thinking or exit timelines. This has allowed us to move with real intent and a long-term vision. 
 

Could you give us an overview of Made’s current capabilities and offering?

Today, we operate out of our roughly 60,000-square-foot facility in Princeton, New Jersey and support multiple cell therapy modalities across both allogeneic and autologous. Our end-to-end offering spans process development, analytical development, technology transfer, and clinical through commercial manufacturing. We currently work with more than 25 projects, one of which has already received FDA commercial approval, paving the way for our path toward FDA licensure for commercial supply directly out of this facility. 

That full range of core CDMO services is where we start, but we also work across essentially every cell therapy sub-modality: MSCs, T cells, TILs, iPSCs, NK cells, and more. What differentiates us is our development team’s depth across not just multiple modalities, but the wide range of different technologies and equipment therapeutic developers are working with, since there is still no single standardized manufacturing approach across the field.

We currently run five active suites in Princeton, and last year, we announced an expansion adding three more suites dedicated to pivotal to commercial manufacturing, scheduled for completion in 2027. This is alongside an additional 45,000 sq ft expansion on this same campus that will be ready in 2028. We are also actively in negotiation for a second site within the region, both for business continuity for our clients and to give ourselves the flexibility to divide capacity sensibly as we provide commercial capacity pathways for multiple pivotal to late phase clients. By the end of this year, I expect we will be positioned to grow from 60,000 square feet toward something closer to 200,000 square feet with scaling capacity in step with the cell therapy space as it grows.

The goal is that every client who comes to us should have a clear path from pivotal to commercial without ever worrying about whether we will have the capacity for them when they need it or competing for capacity with other clients. Since clinical trial enrollment can swing significantly, we never want a client boxed into a timeline or capacity that, if missed, leaves them with no alter-native.
 

Having previously in your career worked inside generalist CDMOs like Lonza, how do you see the case building for a dedicated, pure-play cell therapy CDMO?

Across the competitive landscape you have the large, well-established players like Lonza that are solid and very dependable organisations, but cell therapy is essentially a side interest for them. It will never command the same attention or priority as their established modalities. To be fair, we need those big players to keep those established modalities running well, since by any measure they still account for the vast majority of how patients are treated today.

Then you have small and mid-sized players focused specifically on cell and/or gene therapy. For those companies to survive and succeed, they need the right backing, the right infrastructure, and the right depth of people to stand on their own two feet. Plenty of CDMOs pop up in this space without that foundation and simply can’t sustain themselves. Even combining cell and gene therapy under one roof is too much of a distraction in my opinion. Both fields remain relatively early-stage and cell therapy alone already demands enormous focus. You have to decide precisely what you are good at and where you need to partner instead. Innovators in cell therapy are still evolving their underlying science while needing a CDMO that can deliver on their needs today and in the future. So we made a clear choice to specialize.

Made Scientific fits the small-to-mid-size bucket as we have the right backing, the right infrastructure, including future expansions, and the right people. But the real differentiator is that we have parked our ego and focused on genuine partnerships. Technology, equipment, and platform improvements all matter but our job is developing and manufacturing whatever an innovator brings to us. What innovators are frustrated by is short-sighted CDMOs that promise commercial capacity down the road and eventually can’t deliver. In cell therapy, a company can have strong Phase I data and suddenly find itself under real pressure to lock in a commercial CDMO partner. That is exactly why focus and close partnership matters here.
 

What are the unique needs that Made Scientific needs to address when serving cell therapy innovators compared to traditional pharma and biotech clients?

One key difference is that every cell therapy developer is unique, so the level of personalized service they need varies enormously – from how they want to communicate, to their timelines, to the specific technical requirements of their program. We also talk openly with clients about building what we call a practical, performance-based partnership. Neither side wants a trial to under-enroll, and no client wants to leave a CDMO sitting on empty capacity, but the practical reality of a clinical trial is that it has genuine ups and downs, and nothing is guaranteed. So our partnerships are built around that reality rather than forcing rigid contractual terms or punitive economics onto a process that’s inherently unpredictable. 

Some CDMOs charge separately for every small thing like suite fees, investigations, and deviations, buy we don’t. These considerations are built into the manufacturing price because we know the innovator is doing everything they can to move their product forward and treat patients, so we need to be ready to match that. Flexibility is an easy word to use, but you can’t genuinely claim it while charging clients for everything along the way. Clients also have the ability to watch their own manufacturing runs remotely, in real time, which is something most CDMOs will not offer.

I know what we are putting into the market is disruptive, and it does go against how most CDMOs operate. But the game needs to change, and that is exactly what we are trying to do.


The Made Scientific Foundry is a workforce development and training initiative unique to the organization. What gap in cell and gene therapy manufacturing education and talent is it meant to address?

This actually traces back to BioCentriq’s original workforce development offering that we have since evolved into Made Scientific Foundry™. Foundry supports educational content creation and also facilitates hands-on, practical training. We have partnered with universities, including a public-private partnership with the New Jersey Institute of Technology (NJIT), where we are helping develop course content for one of their biotechnology graduate programs, along with a hands-on training component. These immersive and interactive courses are designed to equip the next generation of industry leaders with the skills and real-world knowledge required to make an immediate impact in the biotech industry.

We have also extended Foundry into advisory work. One example is a leading academic medical center in the Middle East that is investing in building its own cell therapy infrastructure. Rather than simply hiring someone to build a facility, they brought us in as an operator to help them get ready and guide the entire ecosystem toward success. We are providing training there and helping establish platform processes directly with the local government.

Foundry also connects into another pillar of the business through our technology partnerships. There is enormous pressure across the industry to reduce cost of goods, and a meaningful part of that comes through innovations like automation, AI, and new equipment. We are not an equipment company ourselves, but equipment companies need a manufacturing partner to operate their technology and validate real-world use cases. Much like how they would partner with a biotech to run a product through their new technologies, we run proof-of-concept work directly in our facility, sometimes with our own clients involved. 

Manufacturing is consistently cited as one of the field’s central bottlenecks. What’s driving that, and what is Made doing differently?

I agree that manufacturing is a bottleneck, and it is the source of a lot of broken promises made to innovators over the years. But I would argue a lot of that is self-inflicted as a product of a flawed CDMO strategy rather than the underlying science being inherently difficult. The large, established players try to apply traditional modality playbooks onto cell therapy and it doesn’t map as advanced therapies end up getting the least attention internally. Meanwhile, smaller and mid-sized players often create their own bottlenecks through short-sightedness which results in lacking the right capacity, the right people, or the right financial footing. Innovators get told commercial manufacturing capacity will be there when they need it, and then it isn’t, or they are locked into rigid contracts charging them even when patient enrollment slows and there is no product to manufacture. The small companies that are working to develop these therapies can’t survive that.

The other bottleneck is the pace at which manufacturing platforms themselves are evolving. As the pace of new products coming through continues to accelerate, CDMOs and their partners need to bring stability to platforms that are more scalable and lower-cost. Even though each cell therapy product is often built on its own bespoke process, eventually there is convergence, but getting there requires an intentional and focused approach. 

As I see it, one of Made’s core responsibilities is helping innovators get more products approved and to patients faster. Every additional cell therapy approval builds industry-wide experience and knowledge, which helps cultivate more regulatory and manufacturing stability across the board. We are fortunate to be backed by a strategic partner in GC Corp, which lets us stay a step or two ahead of the sector and build a long-term path forward.
 

Earlier this year, the FDA’s Office of Therapeutic Products introduced greater CMC flexibility for cell and gene therapies. To what extent do you see this as a significant step forward in maturing the space?

We have seen directly through our clients that approval timelines remain uneven. Partly because there isn’t much precedent yet. The experience around cell therapy regulation is being built in real time. Just like the industry side, regulatory talent needs developing too. That expertise can either be built from scratch or by training people who already have strong grounding in other modalities. Everyone across the ecosystem needs to do their part in partnering with regulators here, but I have been encouraged by how much acknowledgement there is from the regulators that advanced therapies are fundamentally different from conventional biologics. If the position had remained that these therapies aren’t meaningfully different, we would have a much bigger problem.

While that acknowledgement is the necessary first step, we still have a way to go. The path has certainly been bumpy, but bumps are solvable. I take a glass-half-full view on where the space is today, and I think it falls to CDMOs like Made to actively support both innovators and regulators through this learning process. This is why we are seeing more specialized regulatory consulting firms emerging in the cell and gene therapy space too. As long as everyone’s working toward the same broader goal, it’s a good sign of where we are headed.
 

You have made the point that CDMOs need to take an active role alongside regulators and innovators rather than functioning as a pure service provider. Could you expand on that?

The first priority for any cell therapy CDMO right now should be helping get as many effective products approved as possible. The more approvals we help deliver, the more leverage, attention, and backing the entire space earns. How you run the business commercially is a secondary priority. That mindset is what draws the right CDMOs, like Made, and the right innovators together in this space. If you are primarily focused on a traditional modality and picking up cell therapy on the side, you’ll inevitably treat it as transactional. This field isn’t stable enough yet to be approached that way.
 

As countries push to reshore manufacturing, how do you see this playing out in cell and gene therapy? Is the sector entering an international arms race?

Domestically, innovators overwhelmingly still want to launch their products here in the US first. The US remains the most established, advanced ecosystem in the world, and having manufacturing here is table stakes from a talent, innovation, and market standpoint. 

Here in the US, we keep doubling down on manufacturing because even though cell therapy is inherently localized, the surrounding infrastructure matters enormously. Being based in New Jersey puts us within reach of roughly four major airports, which is exactly why some clients have chosen this location. It lets them serve patients from the East Coast through the Midwest, as well as internationally. That surrounding infrastructure is ultimately something no other country can fully replicate.

Still, the international perspective is also quite interesting. Partners recognize that advanced therapies inherently require some degree of localized manufacturing. Being personalized medicines, geography matters for distribution and treatment timing. What’s encouraged me is the recognition that cell therapy isn’t a modality you can copy and paste from existing infrastructure. In the Middle East partnership I mentioned earlier for instance, there is a real appreciation that building the physical facility is only part of the picture. There needs to be at least a year of dedicated groundwork developing talent and understanding the technology beforehand. In regions where strong hospital systems already exist, converting that into a manufacturing ecosystem requires an entirely different mindset. The sector is recognizing that , which just puts the responsibility on companies like Made to help move the ecosystem forward given how many stake-holders need to be brought to the table.
 

Looking forward, how do Made’s priorities reflect where you see the broader cell therapy field heading?

Through the remainder of this decade, our priorities are built directly around what innovators need: a genuinely dependable CDMO partner capable of navigating clinical-to-commercial manufacturing, who recognizes that the industry still lacks standardized processes and that regulatory expectations are still being worked out. Alongside building the right partnership ecosystem, flexibility and shared economics matter enormously when it comes to making processes more scalable, more platform-based, and lower-cost over the medium to long term. For Made, none of that is achievable without staying purely focused on cell therapy, and without a culture and leadership team that has set its ego aside. 

When we sit down with a biotech innovator, we don’t want them met with the intention to just getting their script and executing without a foundation of mutual understanding. We have built this company to take a personal approach to each partnership we build and tackle the inevitable unseen challenges directly. When I think about how Made will continue to grow, it comes down to culture and staying oriented toward the medium- and long-term rather than the short.

 
Any final thoughts you would like to leave the cell and gene therapy community with?

Innovators should hold CDMOs to a high bar, and CDMOs need to step up, be honest about what they can and can’t deliver, and work toward a shared goal. In cell therapy especially, we are trying to change how this work gets done. Somebody has to go against the grain, and that is exactly what Made Scientific is doing.