Cell Growth & Therapy Unit
Shikhar Mehrotra, PhD
Associate Professor of Surgery
Name: Mingli Li
Location: 2nd Floor Clinical Sciences Building, within SCTR
Equipment and Instrumentation
The Cell Growth & Therapy Unit consists of three components: a 200 ft2 Process Optimization Lab, a 200 ft2 materials Management/QC Laboratory, and a 1000 ft2 clean room suite comprised of manufacturing rooms, general processing area, storage, gowning and de-gowning areas. The cGMP clean room suite contains three annually certified ISO 14644-1 compliant Class 6 manufacturing rooms. Each of these is a fully functional processing laboratory. In addition, each room contains at least one Class 5 Biological Safety Cabinet (BSC) for performing open system sterile processing. The largest of these rooms contains two BSCs. Additional processing equipment includes two COBE 2991 automatic cell processors, a CliniMacs for subset isolation, and centrifuges enabling cell separation. Multiple CO2 incubators and inverted phase microscopes allow all phases of cellular isolation, culture, differentiation, and packaging of final product to be performed inside the clean room environment. An in-lab Accuri C6 flow cytometer is available for cell subset identification and analysis. Sterility testing, including mycoplasma and endotoxin, is performed as required per FDA guidelines. In addition, this laboratory has dedicated refrigerated centrifuges, incubators, microscopes, a Cole Parmer sterile tube welder/sealer, a tabletop autoclave, and controlled rate and cryogenic storage freezers.
- Generation of cGMP Products: The CGTU 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. CET 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 CET is dedicated to scaling up translational studies within the HCC 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 have a research initiative and would like to use the Cell Growth & Therapy Unit, please contact Dr. Shikhar Mehrotra.
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)."