The Therapeutics Cell Manufacturing facility specializes in translating laboratory discoveries into real-world treatments. It is one of only a very few pediatric-dedicated facilities in the U.S. that follows the Good Manufacturing Practices (GMP) for manufacturing therapeutic cell products for early phase IND clinical trials. Since 2012, the team has manufactured products for more than 500 patients in 16 Phase 1 and Phase 2 clinical trials.
Located in downtown Seattle’s biotech corridor, our 11,000-square-foot manufacturing facility has state-of-the-art amenities including 12 cleanroom production suites and dedicated laboratory space for quality control testing and process development. Our services include assistance in process development, establishing timelines and milestones, and budget development for grant proposals.
The Therapeutics Cell Manufacturing facility'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. The team also has the capability to integrate with a third party.
Learn about how the work of the Therapeutics Cell Manufacturing facility team contributed to the FDA Approval of a chimeric antigen receptor (CAR) T-cell immunotherapy treatment for adults with relapsed or refractory large B-cell lymphoma.
How to Get Started
We recommend that researchers who anticipate manufacturing clinical-grade therapies start working with the Therapeutics Cell Manufacturing facility as early as possible for assistance in process development, establishing timelines and milestones, and budget development for grant proposals.
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- 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, Therapeutics Cell Manufacturing facility QC services are available to Seattle Children's Research Institute researchers. These include the following:
- Mycoplasma testing by PCR
- Endotoxin testing by Endosafe PTS
- Bioplex assay