Core C: THE IMMUNOLOGIC MONITORING AND CELLULAR PRODUCTS LABORATORY (IMCPL) will assume responsibility for providing immunologic laboratory support for all three projects in this Program Project Grant. The specific objectives of Core C will be to: 1) procure, process and bank human brain tumor or control tissue specimens as well as body fluids for all projects;2) establish human glioblastoma cell lines from tumor biopsies and maintain as well as expand these lines for preclinical studies;3) culture and evaluate characteristics of human dendritic cells (DC) for use in preclinical studies;4) generate and provide quality alpha DC1 products for therapy of patients participating in clinical trials performed as a part of the Program Project;5) perform all safety testing on therapeutic cellular products;6) perform evaluations of quality and sterility for all cultures and products designed for clinical use;7) develop, evaluate and perform monitoring assays to assess effects of immunotherapy or drug therapy on functions of immune cells, including apoptosis;8) using ELISPOT assays for IFN-gamma production, monitor changes in the frequency of antitumor CTL as a result of vaccine administration to patients with brain tumors;9) measure or serially monitor cytokines and selected growth factors in the tumor microenvironment, body fluids or in cell supernatants. To meet these diverse requirements, Core C will be organized into discrete units as follows: a) a cell production laboratory (CPL) dedicated to culture, maintenance, and evaluation of cells for human therapy (cGMP facility);b) a tissue procurement and processing laboratory (TPF);c) an immunologic monitoring and cytokine unit (IML);and d) a research laboratory for developmental preclinical studies. Core C will operate according to the FDA guidelines for preparation of biologic products for therapy (cGMP) and will maintain good laboratory practice (GLP) standards for performance of monitoring assays.
Showing the most recent 10 out of 105 publications
