Therapeutic Manufacturing Gene and Cell Therapy Laboratory

The Gene and Cell Therapy Lab (GCTC) provides translational researchers with the infrastructure, education, and technical expertise necessary to develop novel gene and cell based clinical products for therapeutic applications.

We assist investigators throughout the process, from the research benchtop, through regulatory communications, to the manufacture of products and infusion of volunteer subjects at the UW CRC.

To ensure the highest attainable level of participant safety, we conduct all activities under a comprehensive quality assurance program that is compliant with current Good Manufacturing Practices (cGMP).

Facilities

The GCTC Lab is located on the UW CRC, facilitating the transfer of patient samples between the clinic and the laboratory. The lab is composed of four secure access critical environment suites (two Biosafety Level 2 suites and two BL3). To prevent cross-contamination of products, each suite is outfitted with dedicated equipment, including biosafety cabinets, incubators, centrifuges and microscopes.

Services

The GCTC lab provides:

• Trained GCTC scientific staff
• Training of investigator staff in cGMP
• Assistance in manufacturing protocol design
• Assistance in writing and submitting Investigational New Drug Applications (INDs) to FDA
• Development of Standard Operating Procedures
• Facility equipment maintenance to comply with regulatory requirements
• Documentation and regulatory support
• Secure archiving of study samples
• Quality Assurance oversight

Investigators provide reagents, biologics and disposables needed for their clinical trial, protocol-specific equipment not available in the GCTC Lab, and technical personnel to assist in manufacturing.