The invaluable asset driving advanced therapies forward

Personalized cell therapies are rewriting the rules of modern medicine. Derived from a patient’s own immune cells, treatments such as CAR T cell therapy have enabled remarkable outcomes for patients who have exhausted other options. Laurie Adami’s remission within weeks after a decade-long battle with lymphoma is one such powerful example.

But for every success story, there are many more patients waiting. For those fortunate enough to receive treatment, lengthy manufacturing processes—prone to delays due to the complex, personalized nature of cell therapies—can jeopardize outcomes. One simulation study found that a six-month delay in CAR T treatment increased one-year all-cause mortality from 34% to 63% for patients with relapsed/refractory diffuse large B-cell lymphoma (1).

This urgency is fueling innovation. New manufacturing technologies aim to streamline production, reduce contamination risks, and automate manual steps. Emerging modalities such as tumor-infiltrating lymphocytes are progressing through clinical trials, promising to expand therapeutic applications. But as these strategies evolve, manufacturers face mounting pressure to keep up with the changes while minimizing batch failure and scaling to meet demand.

Regardless of where the future of cell therapy will go, one foundational need persists: a deep operational understanding of the tools and processes that bring these therapies to life. What if the key to commercializing cell therapies isn’t just the science—but the quality of collaboration with those who support it?

Technology alone isn’t enough

Despite the rise of automation and digital platforms, implementation of new technologies remains a major hurdle. Techniques that work at the bench often don’t translate cleanly to large-scale production, and novel therapies rarely align perfectly with off-the-shelf equipment. Even the most advanced tools can’t deliver results without the right expertise guiding their use.

Add to that the high turnover and burnout rates among manufacturing staff—driven by tight timelines and constantly shifting workflows—and the path to reliable, scalable production becomes even more challenging. In this fast-moving industry, even small gaps in operational knowledge can have outsized consequences.

Understanding and adapting equipment has become essential to navigating scale-up and evolving process needs. It’s more than knowing how a system works—it’s knowing how it behaves under pressure, how it can accommodate process changes, and how to anticipate issues before they escalate. Someone who can identify bottlenecks, troubleshoot in real-time, and guide teams through change isn’t just operating technology—they’re enabling it.

At Cytiva, we call these technology enablers Field Application Specialists (FAS). As ‘on-the-ground’ team members, they’re embedded in the day-to-day realities of cell therapy manufacturing. Whether working with agile startups, hospitals, or established manufacturers, FAS see firsthand what’s working, what’s not, and where the next challenge is likely to emerge. We recently spoke with several members of our global FAS network—and they had no shortage of insights to share.

Enter the Field Application Specialist

Pankaj, an FAS based in India, described the foundation of the role, “Our clients have a core technology but need support in translating it into a manufacturable therapy.” After helping clients decide on the right equipment, FAS support the technology transfer and provide training tailored for the client’s staff and production workflow. “But the journey doesn’t end there,” Pankaj added.

Once a customer is up and running, FAS will continue to support anything from troubleshooting to adapting processes for new products. “Some customers who have had their systems for a while may want to change the process, push the equipment a bit further, or optimize more,” explained Nancy, an FAS based in Scotland. In a field where new technologies and process strategies rapidly evolve, these changes rarely come with a standard playbook.

Simon, an FAS based in Switzerland, put it this way: “The question that comes very often is, ‘What if I don't want to follow the usual path?’” The mindset needed to tackle these questions is at the heart of the FAS role. Will, a US-based FAS, captured it best: “I think being an artist and scientist is similar in the way that you must be creative, curious, and able to understand and solve problems.”

However, the FAS role goes deeper than the job description. “Technical support isn’t just about solving technical issues. It’s also about understanding the customer’s goals and recognizing the importance of those goals from their perspective. That’s why I always strive to go beyond just fixing problems; I aim to deliver deeper technical value. When our customers succeed, I feel that success with them,” explained Jeeheon, a FAS based in South Korea.

Making real-world impact

FAS don’t just support equipment—they enable success. Their deep understanding of cell therapy production, reinforced with experience working across diverse customer sites, enables them to identify problems early, propose creative solutions, and drive meaningful improvements.

From manual cultures to high-performance

Jeeheon recalled working with a client struggling to maintain consistency and efficiency in their cell therapy process. “Their manual cell culturing involved multiple culture vessels and required a significant amount of labor—the researchers were clearly overwhelmed.”

“During a demo session, I had the opportunity to introduce them to our automated solutions. After seeing first-hand how automation can reduce labor and simplify their workflow, they expressed both regret for not discovering the technology sooner and excitement about finally being able to build a robust cell therapy process.”

“Seeing their reaction was incredibly rewarding for me,” continued Jeeheon. “Since then, we’ve maintained a strong and positive relationship with that customer, and I continue to feel proud of the impact we made together.”

Supporting scale up under pandemic pressure

Beyond spotting opportunities for process improvements, FAS are often going above and beyond to lend a helping hand to their clients. Pankaj recalled an experience supporting viral vector vaccine production during the height of the COVID-19 pandemic. This client recently implemented new bioreactors after a rapid tech transfer and needed to scale up production immediately. “They didn’t have time to lose even one batch,” he said. In an effort to save time, Pankaj offered detailed suggestions for scale-up that could suit their process based on his experience.

After implementation, the client told him, “Those suggestions you have given, they are working wonderfully […] the product we are getting is far better than before the tech transfer.” To ensure continued success, Pankaj made himself available around the clock. “I used to keep my mobile on at all times because the batches were running 24/7. They would call me anytime something happened. If there was an issue or troubleshooting, I got involved.”

Accelerating process development

With experience navigating hurdles across a broad range of scenarios, FAS are often first to spot common pain points in manufacturing. Yen, a US-based FAS, has taken a proactive approach to one of the industry’s biggest challenges: the time and resources required to scale up a process. “I recently developed a more precise framework to help customers scale up that’s based on a digital twin,”—a virtual copy of the cell culture, he explained. “Then I do simulation experiments to optimize the culture and grow it to the customer's target yield.”

This approach drastically reduces the number of physical experiments needed. “It takes a couple of days rather than a couple of weeks to get to a point where I think [a customer] would be happy with the results.” Yen recalled one of the first times he used the digital twin: “This client came to us with not a lot of experience in process development with our bioreactor,” he said. But by using the tool to identify starting parameters with less time and resource consumption, “it helped this customer scale up their process and then go into GMP manufacturing in less than a year”—a process that would typically take up to a year and a half.

The value of an extended team

While cell therapy is often defined by its cutting-edge science and precision equipment, it’s the people behind the scenes—like FAS—who ensure that innovation translates into real-world impact. FAS are not just troubleshooters; they’re strategic allies who help manufacturers avoid costly missteps, accelerate timelines, and build more resilient operations.

Operational foresight

One of the most critical contributions FAS makes is helping clients plan for scale early. Without this foresight, companies may find themselves constrained later. “A client may clear the clinical stage only to realize they want to manufacture for hundreds of patients annually—however their processes weren’t designed to support that scale,” remarked Pankaj. At that point, changes are limited, and opportunities have already been lost.

Scaling up requires a shift in mindset that can seem unfamiliar to some researchers. As Simon explained, “You start with a process that was completely manual and you have to automatize it so that you can make more doses to help many patients. Some steps that were taking five minutes are going to take twenty now, and you will have to change the way you're thinking about how you're producing your therapy.” However, it’s these changes that bring consistency, robustness, and productivity to a process.

FAS helps clients navigate these transitions, not only by adapting workflows but by keeping the bigger picture in focus: ensuring therapies reach more patients, faster, and with fewer setbacks.

Getting the right kind of support

FAS also play a vital role in team enablement and knowledge continuity. Pankaj noted that high turnover on the manufacturing floor often leads to gaps in training and knowledge transfer. What may appear to be a quality issue is sometimes just a training need. “Without the training, mistakes will be made, and batch failures will happen. At the end of the day, this is going to affect your delivery time when getting these therapies into the market is very important because the patient is waiting for the therapy,” he said. FAS help fill these gaps, retraining teams and ensuring that critical process knowledge doesn’t walk out the door.

This support is reinforced by a whole network of FAS. Nancy described how FAS team members reach out to each other when specialized expertise is needed, especially in time-sensitive situations. “We're all on the end of a video call, so even if I don't know something, there's someone who does.” With the combined experience of several FAS team members, it’s rare to come across a problem at least one of them hasn’t seen before. That kind of collaboration turns a single FAS into a gateway to a broader support system.

Strengthened partnerships

Beyond the production floor, FAS also strengthen partnerships between clients and vendors. Nancy, who previously worked as customer herself, maintains strong relationships across the industry. “I always check where we've got gaps, so I can tell a customer, ‘Go reach out to this person and they'll help you.’ And then it's vice versa,” she said. Her ability to connect with people and provide honest, unbiased guidance has earned her the trust of clients—some of whom continue to request her input when new projects arise.

Will added that many clients stick with what works and might not engage with vendors about new possibilities, which can lead to missed opportunities. “We, as the suppliers, are trying to improve our products, we're trying to make more offerings that will address unmet needs of our customers, but in order to that, they need to talk to us and help us build a case for it.” When clients open the door to collaboration, they’re often surprised by what’s possible with the support of FAS—whether it’s optimization, upgrades, or custom design.

Rethinking support as a strategic asset

In a field where every day counts, the right support team isn’t a nice-to-have—it’s essential to success. From implementation to troubleshooting to scaling, the FAS bring the insight and agility needed to keep up with this fast-paced industry. As Nancy put it, “for FAS, it’s not just about selling instruments, it’s about support. It’s about pushing science. It’s about curing patients ... I feel that on my shoulders as an FAS— the need to support people and deliver.”

It’s time to rethink vendor partnerships—not as transactions, but as collaborations that shape the future of cell therapy.

The FAS team

• Nancy Coyle: With 26 years in life sciences and 8 years in ATMP manufacturing, Nancy specializes in process development. Since joining Cytiva in 2023, she has supported cell therapy companies in optimizing and scaling manufacturing processes. Her work combines technical expertise with strategic development to help translate therapies from lab to clinic.
• Simon Quenneville: Simon has nearly four years at Cytiva and a background in cell and molecular biology, epigenetics, genomics, and metabolism. He brings expertise in genetic modification, cell culture, and Omics methodologies, including biostatistics. Simon applies this knowledge to enable customer success and support teams across the organization.
• William Lin: William earned a Ph.D. at the University of Chicago and began as a post-doc and product development scientist. Since 2016, he has worked as a field application specialist, supporting end-to-end cell therapy workflows and training professionals through NIIMBL-sponsored bootcamps. Outside work, he enjoys road cycling and BBQ.
• Yen Kong: Yen has six years as a field application specialist, supporting cell therapy customers in process development and GMP manufacturing. He also prototypes new applications based on customer feedback. Previously, Yen helped develop our next-gen rocking bioreactor and researched cell reprogramming and stem cell fate in 2D and 3D systems within academia.
• Jeeheon Kang: Jeeheon leads technical support for manufacturing equipment in gene-modified cell therapy and LNP-based therapeutics. With a Ph.D. in Genetic Engineering, she has seven years of experience helping customers across the Asia Pacific region resolve manufacturing bottlenecks. Based in South Korea, Jeeheon previously worked at Asan Medical Center and enjoys watching baseball.
• Pankaj Salvi: Pankaj supports business development and applications for genomic medicine across the Asia Pacific, including cell therapy and nucleic acid therapeutics. With 15+ years in biopharma, he specializes in optimizing upstream processes and end-to-end solutions, with a strong focus on bridging science and industry. Based in India, Pankaj holds an M.Sc. in Microbiology and enjoys traveling, family time, and gardening.