Manufacturing Cutting-Edge Therapies in the Therapeutic Cell Production Core
At Seattle Children’s, researchers understand that discovering a cure in a laboratory isn’t enough. They must also turn these discoveries into real-world therapies that save children’s lives. That’s why Children’s is completing a multi-million-dollar facility, called the Therapeutic Cell Production Core, which will be among a small handful of pediatric facilities meeting the FDA’s strict requirements for manufacturing therapies.
Advanced Techniques Guarantee High-Quality Therapies
Located in downtown Seattle’s bustling biotech district, the facility contains high-tech clean rooms where the actual therapies will be made. These ultra-pure environments feature an air filtering system that exchanges the air dozens of time an hour, and is pressurized to keep contaminants from flowing in. The rooms' technicians will wear protective clothing and will be required to walk through the facility in a single direction without turning back, so as to avoid carrying potential contaminants from one area to another.
With these and other controls in place, the facility will meet the FDA’s strict “good manufacturing practice” (GMP) requirements. The facility will also contain a dedicated quality control lab to ensure product safety. And, since research bench methods don’t always scale up easily, the facility will be home to a cutting-edge process development lab. There, manufacturing experts will help researchers create standardized manufacturing processes, guaranteeing that all batches of a therapy achieve the highest level of quality.
Innovative Therapies for the Most Challenging Diseases
This facility is already propelling Children’s researchers toward curing some of the most challenging diseases. Its first user was Dr. Michael Jensen of the Ben Towne Center for Childhood Cancer Research. In late 2012, the Jensen lab started Phase I human trials on immunotherapies for leukemia and lymphoma. Once these trials are complete, the lab hopes to conduct Phase I trials on T-cell therapies for many other types of cancer, including neuroblastoma, brain tumors and sarcomas.
Eventually, the GMP facility will be used for Phase II “proof of concept” trials that validate the new therapies’ effectiveness and Phase III trials that compare T-cell therapies to current childhood cancer treatments.
This work is just the beginning. Dr. David Rawlings of the Center for Immunity and Immunotherapies plans to use the GMP facility to refine gene therapies that correct immune disorders. Other Children’s researchers will quickly fall in line and use the facility to make the leap from laboratory discoveries to treatments fit for children.
- Every 20 minutes the amount of clean air pushed through the GMP facility is enough to fill a Goodyear blimp.
- Every two minutes each manufacturing suite undergoes a complete air change.
- All manufacturing processes are performed by at least two production personnel. One person conducts the operation while the other verifies it is done correctly.
- Seattle Children’s is one of only three children’s hospitals in the United States to have a dedicated GMP facility. Seattle Children’s GMP facility is the only one on the West Coast dedicated to pediatric research.