The CPL makes quality products for tumor vaccines and for cellular and gene therapy of cancer, ranging from large-scale therapeutic products to small cultures for pre-clinical studies, and pilot studies to support development of new cell products using Current Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP) conditions. The lab is CAP inspected, CLIA certified, FACT accredited, and maintains a Facilities Master File with the FDA.
CPL Services
The CPL generates and prepares quality products for tumor vaccines and for cellular and gene therapy of cancer, and has developed the methodological expertise required to support clinical investigations of cellular therapies, including:
- Separation and selection of human peripheral blood lymphocyte (PBL) subsets, culture of tumor infiltrating lymphocytes (TIL) or lymph node lymphocytes (LNL) from tumor tissue, and tumor-involved or tumor-draining lymph nodes, respectively
- Culture and modification of peripheral blood-derived lymphocytes, including cytokine-activated T cells (killer T cells), activated natural killer cells (A-NK), and purified CD8+ or CD4+ T cells
- Culture and expansion of cells derived from normal tissues, e.g., skin or synovium, for use in gene therapy or cellular treatments
- Selection and culture of dendritic cells (DC) derived from monocytes in the peripheral blood or from stem cells, using peripheral blood obtained from patients with cancer
- Evaluation of cellular products for functional activity and cellular phenotypes
- Performance of gene transfer into T cells, fibroblasts, DC, or tumor cells and selection of genetically-modified cells
- Clinical grade virus production for ex vivo use in clinical trials
- Expansion of stem cells from neural, mesenchymal and hematopoietic precursors
- Formulation of cellular and peptide products for delayed-type hypersensitivity (DTH) testing, vaccination, and intratumoral, intranodal, intralymphatic, or intravenous administration for therapy
- Storage and release of products manufactured externally
The CPL pilots preparation of new cellular products and assists investigators in preparation of INDs. Once IRB and FDA approvals are obtained, the CPL produces and delivers therapeutic-grade cells to the bedside. Recently, generation of DC-based vaccines and research associated with therapeutic DC generation have been the effort, representing the majority of CPL production activities.
Development of new procedures and products
The CPL provides translational research and development services that are essential for the implementation of future clinical trials and thus benefit multiple users. Examples of recent developmental efforts include:
- Isolation from tissues, culture and expansion of tumor-infiltrating lymphocytes (TIL) for adoptive therapy of solid malignancies
- Manufacture of tolerogenic DC for therapy of autoimmune diseases or post-transplant rejection episodes
- CliniMACS-based separation and expansion of T cell subsets for adoptive therapy
- CliniMACS-based enrichment of CD34+ cells and depletion of CD45RA+ cells for therapy of GVHD
- Expansion of NK-92 cells or primary NK cells for adoptive transfers in patients with hemotological malignancies
- Isolation of autologous HIV-1 and its inactivation: vaccine development for HIV-1 patients
- Pre-clinical studies with production of CART cells
- Clinical grade virus production for patient therapy
