The Center for Cellular Therapy (CCT) is located on the second floor of the Clinical Science Building on at MUSC. The CCT facility houses three fully equipped, FDA/ISO compliant, manufacturing suites available for clinical trials using cell-mediated therapy. CCT is dedicated to scale-up translational studies within MUSC and to support investigator sponsored clinical trials involving cellular therapy. This support includes technology transfer from the research laboratory to the clinical setting, as well as scale-up and validation studies.
The CCT facility consists of three components: a 200 sq. ft. Process Optimization Lab, a 200 sq. ft. materials Management/QC Laboratory, and a 1000 sq. ft. 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, with monthly in-house testing placing them at or below Class 5. Each of these is a fully functional processing laboratory containing well-maintained, highest quality laboratory equipment. 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 BSC’s.
Additional processing equipment provided includes two COBE 2991 automatic cell processors, a CliniMacs for subset isolation, and various centrifuges enabling all types of 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 flow cytometer is available for cell subset identification and analysis. Sterility testing, including mycoplasma and endotoxin, is readily available to be performed as required per FDA guidelines.
The CCT staff has extensive experience in all aspects of cellular therapy and cGMP Phase I/II manufacturing of autologous cellular products. This includes cGTP handling of blood components; dendritic cell, T cell & immunotherapy expertise; as well as clinical experience in transplantation & cellular therapies.
In addition to technical expertise, there is extensive QA/QC and regulatory experience available to ensure FDA compliance during the development of each specific cellular product. CCT staff can provide assistance in the development of standard operating procedures, the performance of process and/or equipment validation, staff training & competency/proficiency assessments, as well as the preparation of regulatory documents including IND applications.
Oversight and resource utilization of the CCT is under the direction of a dedicated committee that meets regularly to assess the progress of on-going clinical trials and to ensure continued compliance with the regulations/standards of all applicable state, federal, and accreditation agencies.
The vision at CCT is to:
Produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current Good Manufacturing Practices (cGMP) as required by federal regulations,
Serve as a regulatory resource to the MUSC in the preparation of cell and possibly in gene-therapy based INDs.
To facilitate clinical development of novel cellular cancer therapies.
CCT Support Activities:
Quality and Compliance
Standard Operating Procedure Development
Operations, Quality and Materials Management
Clinical Trial Budget Preparation
CCT Resources at a glance:
Preparation of standard-of-care cell products for cell therapy
Cell products for experimental IND-based cell therapy
Full-spectrum service from minimally manipulated to extensively cultured cells
Responsive team that develops competency in all cell manipulations, including purification, culture and cytokine expansion, antigen exposure, cell differentiation protocols, and gene transfer
Comprehensive support--starting with IND preparation and regulatory guidance to development of Standard Operating Procedures and product delivery reimbursed by users
Quality management, including quality assurance, quality control, and quality oversight committee
Reporting to regulatory agencies, sponsors, and IRB's of record