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Gene & Cell Therapy Lab

Gene and Cell Therapy Lab

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
  • Immunotherapy 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
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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.