In cell therapy, choosing the right team can make or break your path to the clinic. Organizations large and small wrestle with scaling, compliance, and timelines that rarely feel forgiving. Yet turning to external partners can seem like trading one risk for another—high costs, limited control, and the fear of losing deep process insight. Fast Trak™ solutions aim to challenge these assumptions with services designed to advance therapies and give teams the tools they need to master their own manufacturing process for clinical studies and commercialization.
To understand how Fast Trak™ actually delivers on such a promise, I spent time with leaders from across the global team. From my first conversation, it became clear that calling them a “process development service” barely scratches the surface.
What can Fast Trak™ solutions do?
Process development services may be at the core, but it’s the way they train, guide, and collaborate that makes Fast Trak™ solutions feel less like a service, and more like joining forces with another scientific team.
“We don’t just teach customers how the instruments work, we train them on how to be in the driver’s seat of their own scaled-up, GMP-compliant process,” explained Dr. Masashi Nasukawa, Cell Therapy Sales Specialist.
The team supports a variety of areas to meet organizations wherever they are in their development path:
- Process development services, from single unit operations to fully integrated end-to-end workflows
- Clinical partnerships that help translational centers and organizations prepare for and navigate the path to clinic and beyond
- Educational and hands-on training for any level, including custom courses
- Technology transfer that enables teams to get up and running quickly
- Regulatory support to build a clear roadmap and reassure investors
- Consultation services to help you figure out how to get where you want to go
- New technology evaluations to explore innovations that could strengthen or simplify a workflow
By working side by side with teams to tackle each unique process concern and fill critical knowledge gaps, Fast Trak™ solutions empower organizations to scale, streamline, and set themselves up for clinical and manufacturing success.
Their mission is simple: to help you reach patients sooner.
Who can Fast Trak™ solutions support?
The team described projects from startups with nothing more than a petri dish and an idea or established companies looking to troubleshoot or optimize. They have experience working with modalities across genomic medicine and cell therapy, including CAR T, natural killer cells, TILs, and stem cells, as well as emerging technologies such as lipid nanoparticle delivery.
Dr. Mingming Li, Global Clinical Partnerships Leader, described working with many organizations that have extensive research experience but need support translating their processes to larger scale. A common misconception he hears is that one bioreactor will equal 100 plates. Manufacturing cell therapies is, unfortunately, not that simple. Other teams come to Fast Trak™ solutions because translating research into something scalable and compliant often requires more hands than a small team has. When one organization in this position sent us their cells, “we helped them build an optimized expansion process in a scalable bioreactor, then trained them to run the process on their own”, Mingming recalled. Not long after, this team independently scaled up their process to meet the dosing requirement for IND submission.
And when questions arise that the Fast Trak™ team can’t answer directly, they draw from their global network to bring the right expert to the table.
Accelerating cell therapy process development with Fast Trak™ solutions
Because the scientists in Fast Trak™ solutions know their equipment better than anyone, customers skip months of experimentation and move straight into optimized, ready‑to‑run workflows. By the end of each project, teams walk away with a ready‑to‑use SOP—plus the hands-on training needed to execute it consistently.
One example Dr. Mojtaba Parvizi, Global Cell Therapy Fast Trak™ Services Director, shared still sticks with me. A customer had an established autologous cell therapy process but needed to optimize it for commercial viability. The Fast Trak™ team took a holistic look at the workflow, streamlined critical steps, and ultimately cut two full days of manufacturing time while improving both cell quality and yield.
That combination of technical depth and practical problem‑solving extends to unconventional challenges, too. When one organization wanted to integrate microbeads, rather than the more commonly used nanobeads, into a scalable TCR-T process, Dr. Yi Jin, Cell Therapy Fast Trak™ Services Leader China, worked with them to design a customized approach that both met their needs and simplified their workflow.
The pattern is consistent: when teams tap into the deep technical and practical cell therapy expertise within Fast Trak™ solutions, they can move faster and make clearer decisions about how to advance their therapies.
Personalized training for real-world success
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In addition to hands-on training within a process development project, Fast Trak™ solutions also host educational courses that range from cell therapy basics, advanced manufacturing strategies, and customized sessions tailored to a customer’s needs and workflow. These courses are often used to upskill talent and train staff, including process development teams who need to learn how to run Cytiva equipment or new workflows. The customized courses are often the most impactful, especially when run at a customer’s facility using their process and materials, Sabrina Carmichael, Global Technical Leader of Fast Trak™ services, explained. What stood out to me is how detailed these courses can get. Sabrina does more than teach the concepts. She rolls up her sleeves and walks teams through the practical details that could otherwise take months of trial and error to figure out. She’ll dive into whatever specifics are needed, all the way down to demonstrating exactly how she makes sterile connections in her own lab. And the relationship doesn’t end when the course is done. Sabrina keeps in touch with the teams she works with, sending follow‑up resources and answering questions long after the course wraps up—a testament to how invested they are in the people behind the science. |
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Staying ahead in cell therapy through continuous learning
Fast Trak™ solutions go beyond helping teams with today’s challenges by constantly exploring what’s coming next. By collaborating with translational centers and academic groups at the forefront of emerging cell therapies, they stay connected to new ideas, trends, and technologies.
Talking with our team members around the world, it became clear that this outward focus isn’t coincidental. Rather, it reflects a culture built on continuous learning and driving scientific progress that ultimately benefits the organizations they support.
For those in cell therapy evaluating CDMO options, Fast Trak™ solutions provide more than process execution; they act as “an extended arm of scientific teams,” working side‑by‑side to experiment, troubleshoot, and iterate.
When you zoom out, what makes Fast Trak™ solutions special isn’t just their expertise, it’s the way they show up to support teams, even long after a project ends. And they do it with curiosity, humility, and an eagerness to help that you can feel from the moment the conversation begins.
What to expect when working with Fast Trak™ solutions
Collaboration is at the center of every Fast Trak™ project. If you’re considering reaching out, here’s what the journey typically looks like:
First meeting
Every project begins with a conversation. You’ll sit down with the Fast Trak™ team to discuss your goals, what you’ve tried so far, the systems you’re using, and where you’re looking for support.
Proposal
With that context, the team will develop a proposal outlining timelines, costs, and key milestones—giving you a clear picture of what the project will involve from the outset.
Statement of work
Next comes the statement of work (SOW), which lays out every step of the agreed-upon proposal in much greater detail. Project scope, plan, timelines, targets, and deliverables will get defined and there’ll be alignment on aspects including critical quality attributes (CQAs) and critical quality points (CQPs).
This stage is intentionally iterative. “We want them to know we don’t dictate the plan,” Sabrina explained; it’s built based on your experience, needs, and insights.
Project execution
When the SOW is finalized, execution begins with technology transfer of your process to a Fast Trak™ site. Timelines vary—some projects take two weeks, others six months. Throughout the project, you’ll have regular meetings to review data, track progress, and adjust plans as needed. “All the problems are discussed and solved in consensus, so they don’t see us as a separate team,” added Mojtaba
Outside these meetings, lines of communication remain open, so you always know what’s happening.
Final meeting
At project completion, you receive all deliverables—SOPs, raw and compiled data, bill of materials, and everything else required to begin engineering runs and move toward a GMP process.
Tech transfer and training
The last step is on-site tech transfer training to ensure your team can confidently run the process independently. This hands‑on walkthrough covers exactly how the work was performed and how your team should execute it moving forward.
If your facility isn’t ready yet, training can also take place at a Cytiva site.
Ongoing support
That won’t be the last time you hear from the Fast Trak™ team, though. Whether it’s weeks or months later, they’ll remain available to troubleshoot, answer questions, or loop in a field application specialists (FAS) when needed.
FAQ
Does Fast Trak™ solutions support GMP compliance?
Yes. Fast Trak™ solutions use GMP-grade equipment, technology, and materials for process development so that once the process is transferred to your manufacturing site for CMO, you’ll be ready for engineering runs. They also ensure that media or reagents included in a customer’s workflow meet the necessary compliance expectations.
Does Fast Trak™ solutions work with third party instrumentation?
Absolutely. Fast Trak™ labs include a full suite of third‑party equipment in addition to Cytiva systems. Customers are often surprised by the range of technologies available, which allows Fast Trak™ to design and run processes using the specific tools that is more suitable to a customer’s process.
Can Fast Trak™ solutions support with regulatory approval?
Yes. Fast Trak™ solutions work closely with the regulatory team at Cytiva to stay aligned with global requirements. They help customers understand what is needed for their specific regulatory filings and, when beneficial, they connect customers directly with Cytiva regulatory experts to ensure clarity and accuracy.
What’s the difference between Fast Trak™ solutions and a CDMO?
The Fast Trak™ team is closely integrated with customer teams rather than operating as an external contractor. Intellectual property always remains with the customer, and the work is carried out transparently, with joint planning, shared troubleshooting, and continuous communication.
Additionally, Fast Trak™ solutions do not manufacture therapies themselves, but they do set teams up with everything they need for GMP manufacturing at their facility or CMO of choice and continue to provide support as needed after the project ends.
Read more: CDMO or no CDMO… that is the question
Meet (some of) the team
From left to right, top to bottom:
Sabrina Carmichael: Sabrina brings experience from Boston Children’s Hospital and R&D at Cytiva to her role as Global Technical Leader for Fast Trak™ solutions. She specializes in translating complex workflows into practical, hands‑on training that helps teams adopt new processes efficiently and confidently.
Dr. Mojtaba Parvizi: With a PhD in stem cell therapy and research experience at Mayo Clinic, Mojtaba now leads the global Fast Trak™ services cell therapy team. His background in translational science enables him to guide customers through process optimization that reduces timelines while improving quality and consistency.
Dr. Mingming Li: Mingming’s foundation in stem‑cell science, clinical trial management, and global translational support informs his work leading clinical partnerships Cytiva. He helps organizations bridge the gap from early research to scalable, GMP‑ready manufacturing and beyond.
Dr. Masashi Nasukawa: Masashi draws on deep expertise in microalgae culturing, antibody production, and perfusion processes to support organizations across Japan. His background in building scalable culture systems helps customers develop fully tested and reliable cell therapy workflows for their unique needs.
Dr. Yi Jin: Yi, a PhD virologist and former field application scientist for Cytiva, leads Fast Trak™ cell therapy services in China. His combined product management and scientific experience are powerful tools he applies to his current work in designing scalable cell therapy manufacturing processes and supporting Cytiva China innovation projects with technical rigor.