Quality Control
The Therapeutics Cell Manufacturing facility’s laboratory space supports more than 120 faculty and staff members, and houses the quality control and process development labs. Quality control personnel perform in-house tests, coordinate outside testing on manufactured products and perform release testing to ensure products are safe, pure and potent before they are released in patients. The quality control team works closely with the process development lab, beginning at the early stages of development, to monitor the developing manufacturing process.
Release Testing Services
- Endotoxin testing
- Mycoplasma testing
- Viability
- Cell surface phenotype by flow cytometry
- USP bacterial and fungal testing (in collaboration with Seattle Children's Hospital Microbiology)
- Vector copy number, qPCR
Assay Development
- Generation and optimization of new analytical assays for release testing or other required testing
- Qualification of assay reagents
- Equipment/instrument qualification
- Assay optimization
- Assay validation/qualification