PROGRAM FOR ADVANCED CELL THERAPY
- The mission of PACT is to develop healthcare-friendly solutions for novel cell therapies and devices in order to improve patient outcomes.
- To strive for the best patient outcomes as our primary endpoint
- To provide quality and excellence in FDA phase I/II compliant cell manufacturing
- To create a model for distributive justice, technology access and sustainability
- We specialize in conducting first-in-human clinical trials to de-risk advanced cell therapy leveraging UW Health expertise in clinical domains of excellence.
- We empower our academic and industry partners to translate scientific discoveries to cell therapies through FDA CBER investigational new drug (IND) application-enabling and Phase I/II clinical studies.
- We have expertise in utilization and optimization of partially and fully automated closed systems for advanced cell manufacturing and enrichment.
- We maintain and continuously improve our operating procedures and quality system to meet cell therapy-specific FDA CBER guidance for Phase I/II clinical trials.
- We welcome academic and industry partners to work with us in the design or improvement of innovative and existing technologies and devices that may be integrated into cGMP cell manufacturing workflow and deployed within real world health system operations.
CELL MANUFACTURING FACILITY
Cell manufacturing is performed in the ISO 7 cleanroom integrated within the UW Health hospital. The facility houses an ISO 7 cleanroom and independent ISO 8 gowning/storage room and degowning rooms. The facility is continuously monitored by a Rees Centron® monitoring system. Viable and non-viable particulates are routinely monitored for quality control purposes. All instrumentation and equipment housed within the facility is certified, calibrated and qualified to operate within specification design parameters.
QUALITY CONTROL LABORATORY
UW Health is currently planning a facility expansion to house a segregated quality control laboratory and space for secure storage of manufacturing, facility maintenance and QC testing materials. The new space will also include increased cell cryopreservation capacity.
GOOD MANUFACTURING PRACTICES (GMP)
All PACT actions are performed under current Good Manufacturing Practices by the FDA’s guidance for cell and gene therapy phase 1 clinical trials. The program is quality audited by independent, UW Health Clinical Labs Quality Assurance personnel for compliance to current SOPs and continuous quality improvement.