- Amittha Wickrema, PhD
- Diane Ostrega, MS MBA
- Thomas F. Gajewski, M.D., Ph.D.
- Yuanyuan Zha, Ph.D.
The Human Immunologic Monitoring-cGMP (HIM-cGMP) Facility provides resources to support UC investigators who wish to conduct novel immunotherapy clinical trials.
The HIM Subcore enables a range of clinical researchers who don't necessarily have laboratory expertise or facilities themselves, to measure immunologic endpoints and evaluate changes of immune response parameters in response to immunotherapeutic interventions in participating study subjects. The Facility also monitors biologic effects of other pharmacologic agents (such as signal transduction inhibitors) using lymphocytes or other hematopoietic cells as a surrogate tissue.
The current Good Manufacturing Practice (cGMP) Subcore was integrated with the HIM in 2011. Since it inception it has been the resource in which therapeutic cancer vaccines have been manufactured. The cGMP Subcore is registered with the FDA in accordance with 21 CFR part 1271 that requires registration of clinical facilities engaged in the production of products for administration to patients. The design of suites within the clean room environment allows for campaigns of multiple therapeutic products to be in production at any given time without cross-contamination. The Facility is capable of providing services for Phase I, II, and III clinical trials. To see the full range of services offered by the HIM-cGMP facility click on the Services tab on the navigation bar above.