Therapeutic Cell Production Core (TCPC)

TCPC Overview 

The Therapeutic Cell Production Core (TCPC) specializes in translating laboratory discoveries into real-world treatments. It is one of only a very few pediatric facilities in the U.S. that meet the FDA's strict Good Manufacturing Practice (GMP) requirements for manufacturing therapeutic cell products.

The TCPC's state-of-the-art amenities include a 4,700-square-foot clean room space, a quality control lab and a process development lab. The TCPC's expert team helps researchers navigate every step in the process of adapting research laboratory methods to a manufacturing environment, including required release testing, final product characterization and regulatory support.

Our Services

• Assistance developing budgets for grant proposals
• Pre-clinical assistance, analytical assay and manufacturing process development, product scale-up and clinical grade reagent/materials sourcing
• Consultation for regulatory submissions (IND, IRB, NIH, IBC)
• Development of standard operating procedures for manufacturing
• GMP-compliant documentation
• Full-service manufacturing by highly-trained manufacturing staff
• Quality control/in-house testing of manufactured products
• Coordination and facilitation of offsite testing
• Product transport to clinical sites
• Long-term manufacturing archiving
• Quality assurance oversight to ensure clinical product safety and regulatory compliance

In addition to quality control (QC) testing performed in support of clinical manufacture, TCPC QC services are available to Seattle Children's Research Institute researchers. These include the following:

• Mycoplasma testing by PCR
• Endotoxin testing by Endosafe PTS

Hours of Operation and Location

Links and Resources

1. TCPC website

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