Seattle Children’s new cell production facility helps turn laboratory discoveries into lifesaving therapies – starting with cancer immunotherapy.

Seattle Children’s Research Institute’s new Therapeutic Cell Production Core (TCPC), housed in the Olive Lab facility, is one of just a handful of pediatric facilities that meets the FDA’s “good manufacturing practice” (GMP) requirements for manufacturing therapies.

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In 2013, it opened its doors and enabled the launch of Phase I and Phase I/II trials using genetically reprogrammed T cells for children and young adults with relapsed acute lymphoblastic leukemia. This early success illustrates how the TCPC accelerates progress by giving Seattle Children’s researchers the opportunity to turn their laboratory discoveries into real-world therapies.

“Most GMP facilities are owned by pharmaceutical companies and it isn’t cost-effective for them to pursue cures for pediatric diseases since they affect relatively few patients,” says Dr. Michael Jensen, who directs the Ben Towne Center for Childhood Cancer Research. “Having a GMP facility lets us take matters into our own hands.”

Ensuring therapies are safe and pure

“Manufacturing clinical-grade therapies is completely different than growing cells in a research lab,” says Catherine Lindgren, who leads the TCPC. “You have to use different materials, and you have to scale up production without losing quality.”

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Lindgren and her team guide researchers through each step in this process. This starts in the TCPC’s process development lab, where lab staff help researchers choose clinical-grade reagents and develop processes that ensure therapies are made the same way every time.

The actual manufacturing takes place in a 4,700-square-foot clean room, where technicians manipulate the genes inside cells and perform other key tasks. Then the TCPC’s quality control lab tests each batch of a therapy product to verify it is safe, pure and potent enough to be used in patients.

Developing promising leukemia therapies

The TCPC is supporting a Phase I/II trial that uses engineered T cells to treat patients with relapsed acute lymphoblastic lymphoma (ALL). The therapy put its first two patients into remission.

“Without having our own GMP facility, we would have had to rent time at other facilities and wait in line,” Jensen says. “It would have taken us much longer to move these trials forward, and it probably would have been too late to help these patients.”

The TCPC is also being used in another Phase I/II trial that evaluates an immunotherapy treatment for ALL patients who have relapsed after undergoing a bone marrow transplant. The facility will ultimately be used by investigators from throughout Seattle Children’s and has the capacity to manufacture therapies for as many as 200 patients a year.

Fulfilling a vision

The immunotherapy trials were exactly what Dr. Jim Hendricks, president of the research institute, and Dr. Bruder Stapleton, Seattle Children’s chief academic officer, envisioned in 2010, when they made a gutsy decision to complete the TCPC. The economy was in a severe recession and Seattle Children’s was able to buy the facility’s infrastructure – and lease the building that housed it – at fire-sale prices. Still, the facility needed to be refurbished and the recession made it a risky time to take on this financial commitment.

Hendricks and Stapleton moved forward because they knew the TCPC could play a key role in curing childhood diseases. And completing the facility helped them convince Jensen, who was then at City of Hope in Los Angeles, to lead Seattle Children’s push to become a world leader in pediatric cancer research.

“The pieces fell into place at exactly the right time and the results have been beyond my wildest imagination,” Hendricks says. “It’s almost like it was destiny.”

“The pieces fell into place at exactly the right time and the results have been beyond my wildest imagination. It’s almost like it was destiny.”
– Dr. Jim Hendricks