Program for Advanced Cell Therapy

Integrated personalized cell technologies for improving health outcomes in children and adults
Immunohistochemistry photo collage

The Program for Advance Cell Therapy (PACT) focuses
on healthcare integrated personalized cell technologies for improving health outcomes.

PROGRAM FOR ADVANCED CELL THERAPY

MISSION:

  • The mission of PACT is to develop healthcare-friendly solutions for novel cell therapies and devices in order to improve patient outcomes.

CORE VALUES:

  • To provide quality and excellence in FDA phase I/II compliant cell manufacturing
  • To strive for the best patient outcomes as our primary endpoint
  • To create a model for distributive justice, technology access and sustainability

SERVICES AND PARTNERSHIPS:

  • We specialize in conducting first-in-human clinical trials to de-risk various aspects of advanced cell therapy. We empower our partners to transition 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 of partially and fully automated, closed systems for cell manufacturing. Our team of experts optimizes the manufacturing processes, including FDA-compliant production of a variety of cell types, advanced cell manufacturing and cell enrichment.
  • We provide assistance in development of standard operating procedures and batch production records in support of new FDA CBER INDs.
  • We offer services to assist researchers and clinicians in various aspects of IND filing including writing/reviewing of chemistry, manufacturing and controls (CMC) and supporting reports.
  • We participate in single center and multi-center trials for academic and clinical-stage companies in the cell technology space.
  • We partner with biotechnology and medical device companies to integrate their semi-automated and fully automated devices to improve good manufacturing practice (GMP) workflow.
  • We welcome academic and industry partners to work with us in order to design new technologies/devices or improve existing technologies/devices that may be used in the GMP cell manufacturing laboratories.
  • We serve as a beta site for testing any processes that will improve GMP laboratory practices and workflows.

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.