For more information on these services, please visit the Center for Cellular Therapy. If you have a research initiative and would like to use the Center for Cellular Therapy, please contact us at email@example.com.
Generation of cGMP Products: The Center for Cellular Therapy staff has extensive experience in all aspects of cellular therapy and cGMP Phase I/II manufacturing of autologous cellular products. These include cGMP handling of blood components; dendritic cells, mesenchymal stem cells, T-cell & immunotherapy expertise; and clinical experience in transplantation and cellular therapies. In addition to technical expertise, extensive QA/QC and regulatory experience are available to ensure FDA compliance during the development of each specific cellular product. Staff can provide assistance in the development of standard operating procedures, performance of process and/or equipment validation, staff training and competency/proficiency assessments, and preparation of regulatory documents including IND applications. The Center for Cellular Therapy is dedicated to scaling up translational studies within the Hollings Cancer Center and supporting investigator-initiated clinical trials involving cellular therapy. Support includes technology transfer from the research laboratory to the clinical setting as well as scale-up and validation studies.
Immune Monitoring: Immunomonitoring allows the characterization and quantification of immune cells (lymphocytes, monocytes, dendritic cells), identification of "rare" sub-population of cells (e.g., flow cytometry techniques combining multiple parameters), and the study of complex immunological functions (cell proliferation, antigen presentation, synthesis of cytokines, antibodies or other biomarkers, gene expression profiles). For example, the DC validation essential for conducting DC clinical trials involves characterization of the DC phenotype using the cell surface markers CD14, CD80, CD86, HLA-DR. The PBMCs collected at different time points are evaluated quantitatively for tumor epitope specific T-cells using tetramer staining, ELISPOT, and qualitatively by ELISA. For studies examining mesenchymal stem cells, suppressive functions of the MSCs are tested in a suppression assay that determines the proliferation of CD3 T-cells in presence or absence of MSCs at various E: T ratio.
If you publish a manuscript including research supported by the Cell Evaluation & Therapy Shared Resource, the HCC recommends the following text to be placed in the acknowledgement section: "Supported in part by the Cell Evaluation & Therapy Shared Resource, Hollings Cancer Center, Medical University of South Carolina (P30 CA138313)."