Key takeaways about the CAR-T manufacturing and delivery process
- CAR-T cell therapy is a type of personalized treatment that works by harnessing a person’s immune system, or T cells, to fight certain types of cancer.
- CAR-T cell therapy for multiple myeloma is delivered as a one-time infusion and offers patients a treatment-free period from ongoing cancer treatments. In some patients, this period may last for years.
- Jessica Torfs leads the global planning and delivery of the CAR-T manufacturing and supply chain process at Johnson & Johnson.
- Torfs’ responsibilities cover the vein-to-vein patient journey, which includes making sure the patient’s T cells are collected, reprogrammed and returned to be infused into the patient as quickly as possible.
Jessica Torfs will always remember the awe she felt the first time she saw a cancer patient’s immune cells.
She’d just started her role as a CAR-T supply chain manager at Johnson & Johnson and was touring one of the company’s manufacturing facilities. Torfs was no stranger to manufacturing sites. She’d spent her career working in manufacturing operations and distribution centers and had seen plenty of packaging lines, chemical reactors and complex machinery.
But that day, when she walked into a “cleanroom”—a tightly controlled environment where everyone follows strict gowning and handling procedures to ensure a sterile space—everything felt different. She watched a cell lab operator carefully lift a small, transparent container filled with salmon-colored blood and transfer it to an incubator.
“That’s it,” the cell manufacturing operator said. “That’s where our manufacturing process will convert this patient’s T cells to the CAR-T cells that we will ship back to him.”
In that moment, Torfs realized the magnitude of what she had just witnessed—and the importance of the role she’d taken on. Inside that incubator were the immune cells of a multiple myeloma patient who was counting on Johnson & Johnson to transform those cells into ones that would recognize and attack his cancer. Once the cells were transformed, Johnson & Johnson would then send them back to the patient’s healthcare team to infuse back into his body.
Torfs realized that manufacturing CAR-T cell therapy isn’t just about producing treatment. It’s about remembering that every part of the process is personalized and connected to a patient waiting for treatment.
“When people ask me, ‘What is CAR-T?’ I tell them it’s a game changer that brings new hope to patients,” she says.
Knowing that there’s a person waiting on the other end of the process really brings clarity to what our priority should be.
A highly coordinated process
Chimeric antigen receptor (CAR)-T cell therapy is a type of personalized therapy that genetically modifies immune-system cells called T cells so they recognize and attack cancer cells. Johnson & Johnson collaborates with Legend Biotech to manufacture one of these CAR-T therapies approved for the treatment of multiple myeloma, a type of blood cancer.
Every CAR-T therapy delivered to a patient is the result of meticulous planning, coordination and a commitment to quality at every stage, says Torfs.
It starts with collaboration. Johnson & Johnson works with healthcare teams at more than 350 hospitals and medical centers across 20 markets on the CAR-T process. These medical institutions collect T cells from patients with multiple myeloma using a specialized machine to select the cells from the blood (a procedure known as apheresis). They then work with Johnson & Johnson to coordinate the prompt collection of those cells on the requested pickup date.
The cells are then shipped to a cryopreservation facility, where they are frozen to maintain viability and quality until the manufacturing process begins.
“Once we receive the cells, we bring them to a cleanroom to thaw and wash them so the operators can select the T cells that we need,” explains Torfs. “Then we add lentiviral vector, which is the key ingredient that transforms those T cells into CAR-T cells.”
This step reprograms the genetic material of the patient’s T cells so they’re able to identify and target the cancer cells. Think of these engineered T cells as super powered immune cells, able to travel throughout the body to recognize cancer cells and kill them.
For these new and improved T cells to get to work, they must be tested with multiple quality checks before they can be transported back to the hospital on an agreed-upon day, at which point they’ll be ready for infusion back into the patient’s body.
Because CAR-T is a personalized therapy, the time from cell collection to infusion varies by patient. While manufacturing and quality testing are key steps, the overall timeline also reflects treatment center scheduling, logistics and any bridging therapy needed to support patients before infusion.
Navigating the unexpected
Torfs oversees the roughly 80 employees who work in shifts to make sure these complex logistics run as smoothly and quickly as possible while meeting rigorous quality standards at every step.
Day to day, this means focusing on the strategic direction of global CAR-T supply chain operations and removing roadblocks, such as sudden flight-schedule changes, that have the potential to disrupt any part of the manufacturing or delivery of these critical cells. It also involves making sure teams across departments tackling very different aspects of the process are aligned and working together.
Recently, Torfs has also started leveraging artificial intelligence (AI) to improve Johnson & Johnson’s service to patients even further by automating processes where and when it makes sense.
Unlike many drug manufacturing processes, where treatments are made and then stored as inventory, when Torfs’ team receives notification of a new batch of a patient’s cells, the clock starts—and the stakes are high.
“In an ideal scenario, a patient’s cells get picked up and delivered on time, the weather is great for delivery and every step of the process works perfectly,” says Torfs. “However, as is the case with any type of manufacturing and delivery process, unexpected things can happen. We have to deal with hurricanes, heat waves and even local events that shut down airports.”
When this happens with more traditional manufacturing operations, there’s typically inventory—shelves full of stock that allow the manufacturer some time to resolve the situation. With CAR-T therapy, there’s no time to lose.
“Patients put their faith in us, and we make a promise to deliver their reprogrammed cells back to them on a specific date,” says Torfs. “So while we encounter the same type of obstacles that any operational environment faces, the difference is that we need to resolve them within a much tighter timeframe to maintain our promise.”
Torfs thrives on the pressure. “I’m an operations girl—and love being kept on my toes. The challenge is high, but so is the reward.”
Building a thoughtful supply chain from the ground up
Behind the scenes, the many moving parts of CAR-T manufacturing and delivery are nearly invisible. Teams across multiple departments coordinate every step of the process with remarkable precision. In fact, everything often works so seamlessly that the complexity is easy to miss.
Torfs compares it to a duck gliding across a lake. On the surface, everything appears calm and effortless. Beneath the water, the duck’s feet are paddling nonstop to keep it moving forward.
Over the years, Torfs and her team have delivered CAR-T therapy to more than 14,000 multiple myeloma patients across 20 markets in North America, South America, Europe, the Middle East and Asia Pacific. They built a system from day one that was intentional—filled with rigorous controls, reviews and the ability to learn and self-correct along the way.
“We’re continuously looking for potential vulnerabilities and adjusting our process,” she says. “That is our mindset.”
Take what’s known as “chain of identity and custody,” for example. To ensure the team delivers the patient’s cells back to the correct patient, there’s a specialized system with multiple processes in place.
“Every employee who touches the product is trained, knows how to use the system and understands how to confirm and double verify that everything was done correctly for each individual patient,” she says.
Building such a detailed and precise system “has allowed us to be very intentional about safety while continuously refining our processes as we move forward,” says Torfs.
Keeping patients at the center
For all the high-stakes steps involved in manufacturing and delivering CAR-T cell therapy, Torfs says her team’s focus is actually quite simple: the patients.
“Knowing that there’s a person waiting on the other end of the process really brings clarity to what our priority should be,” she says. “The patients are our north star. Every single department knows the goal is to get the product back to the patient on the day we promised. I’ve never had that clarity before in any of the other jobs I’ve held in my career.”
While every therapy Torfs and her team work on is made for one patient at a time, the hope is that in the near future, even more patients might benefit from cell therapies. Torfs is focused on scaling her team’s ability to serve an even greater number of multiple myeloma patients, but she’s also thinking bigger.
“We are constantly asking, ‘How can we bring this innovative science to more people?’” she says.
For Torfs, this connection to the patients she serves and her hope for a future filled with even more patients benefiting from CAR-T therapies gives her a powerful sense of purpose—and pride.
In the six years since that day in the cleanroom, when one small container became so much more than a sample of cells, Torfs has continued to experience the same sense of awe. She says it’s especially present every time Johnson & Johnson partners with a new hospital in a new market.
“Every new region that launches goes through what I call the honeymoon phase, and I get to experience their excitement again and again through their eyes,” says Torfs.
“This work will leave a mark on my life forever,” she adds. “I already know that when I retire, this is the job I’ll tell my grandkids about. I’ll always be grateful for the impact I have been able to have.”
