W.W. Williams Company Cell Therapy Laboratory
The new James Cancer Hospital and Solove Research Institute includes a ramped-up Cell Therapy Laboratory (CTL) that can produce clinical-grade living cells for use in immune therapy research.
The lab follows Good Manufacturing Practices (GMP), which are required for the production of pharmaceutical and biologic agents.
“The new lab expands our capabilities from the traditional preparation of cells for bone marrow and stem cell transplant to W.W. Williams Company Cell Therapy Laboratory the production of therapeutic cell products for use in immune therapy trials,” says CTL Director Lynn O’Donnell, PhD, associate professor of Hematology.
“The CTL will allow OSUCCC – James investigators for the first time to conduct phase I and phase II clinical trials to evaluate cellular immune therapies that are based on their own preclinical research.”
The 2,500-sq.-ft. facility, located on the hospital’s first floor, has two clean rooms and a highly trained, expert staff.
“Our researchers will drive the types of cells we handle,” O’Donnell says. “If they are studying a cell type that has therapeutic benefit, we will learn how to produce that cell type.”
O’Donnell expects the Cell Therapy Lab to produce cells for two clinical trials during its first year of operation and to open another three or four studies during its second year.
“Patience is essential for these studies,” she says. “A significant amount of work is required to scale up from animal studies to human studies.”
It typically takes one to two years to work through the optimization and scale-up phases of a project.
Highlights of the Cell Therapy Laboratory
- The two ISO Class 7 clean rooms are equipped for investigational cell-therapy products, which require a high level of air quality, extensive staff gowning and additional process controls.
- The lab includes a separate quality control room for testing cell therapy products, as required by the FDA.
- It is equipped with cell-selection devices, automated processors, a bioreactor, an eight-parameter flow cytometer, and cryopreservation and storage equipment.
- The lab maintains extensive cleaning and sanitization, environmental monitoring, batch production, materials management and process-validation records.