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A Comprehensive Cancer Center Designated by the National Cancer Institute

Human Immunological Monitoring-cGMP Facility

Scientific Co-Directors: Thomas F. Gajewski, MD, PhD, and Amittha Wickrema, PhD
Technical Directors: Yuanyuan Zha, PhD (HIM), and Diane Ostrega, MS, MBA (cGMP)

The Human Immunologic Monitoring-cGMP Facility provides service to clinical cancer investigators to prepare clinical-grade products, and to measure immunologic endpoints and other pharmacodynamic parameters in subjects participating in clinical trials. The facility serves as a specialized laboratory to perform scientific analyses that include: 1) evaluating changes in immune response parameters in response to immunotherapeutic interventions; 2) monitoring biologic effects of other pharmacologic agents using lymphocytes or other hematopoietic cell subsets as a surrogate tissue; and 3) preparing clinical-grade products, such as cancer vaccines, for administration to patients. The Facility also has flexibility to develop new assays when needed for specific scientific questions.


  • Preparation of peptide-based cancer vaccines
  • Vialing of cGMP-grade peptides and quality control
  • Isolation of specific cell subsets from PBMCs
  • Isolation of T cell subsets from viably frozen tumor biopsies
  • mRNA isolation and qRT-PCR analysis of gene expression profiling data in the tumor microenvironment
  • Preparation of RNA sample from cells or tumor biopsies for microarray analysis
  • Preparation of tissue samples for immunohistochemistry
  • DNA, RNA, and microRNA isolation from in vitro stimulated T cells
  • In vitro priming for antigen-specific CD8+ T cells
  • ELISPOT for IFN-γ and other cytokines
  • Peptide/tetramer or dextramer analysis
  • Flow cytometric staining for specific T-cell subsets and activation markers
  • PHA-induced T cell proliferation
  • NK cell cytolytic activity
  • Intracellular FACS analysis for cytokines and/or other proteins
  • ELISA assays for specific factors in serum, plasma, and other body fluids
  • Western blot analysis for specific signal transduction intermediates
  • Data analysis, assistance in grant proposals, budget preparation