The ITHS Gene and Cell Therapy Lab (GCTL) offers the infrastructure, technical expertise and regulatory expertise needed to develop and manufacture novel gene and cell therapy products. The typical users and types of studies of the GCTL include:
Stem cell therapy investigators
Cord-blood transplant investigators
Clinical investigators pursuing clinical vector technology for therapies
The GCTL is a 2,200 square-foot clean room facility located in the ITHS Clinical Research Center in the University of Washington Medical Center. It has four separate ISO class 7 BL2 suites (with two suites under negative pressure). Each suite is equipped with biosafety cabinets, incubators, centrifuges, and refrigerators. It has a CliniMACS® cell selection system for cell enrichment and /or cell depletion. The facility is also equipped with a controlled rate freezer and LN2 vapor storage system. The equipment is continuously monitored by a validated Reese Centron® monitoring system.
How We Help
ITHS offers services such as the following to support your research:
Trained GCTL scientific staff to support product development and manufacture
Training of investigator staff in current Good Manufacturing Process
Pre-clinical studies consultation and process development
FDA regulatory filing support for Phase I/Phase II Clinical Trials
Assistance with the Chemistry, Manufacturing, & Controls (CMC) section of IND applications
Development of standard operating procedures
On-site cryopreservation and secure archiving of study samples
Secure archiving of study samples
Quality assurance oversight
Contact Us / Ask the Research Navigator
Ask the Research Navigator
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