Center for Cellular Therapy

The Center for Cellular Therapy (CCT) is a university shared-core resource that is dedicated to scale-up translational studies and supporting investigator-sponsored clinical trials involving cellular therapy. The CCT is an FDA registered cGMP level facility that meets the most rigorous standards in the aspect of processing of cells and has 3 cGMP grade manufacturing suites for cellular production.

The Center for Cellular Therapy is continuously striving to push forward the boundaries of medicine, both at MUSC and nationally. We have the capacity to partner with MUSC investigators and outside biotech and pharmaceutical companies to manufacture cellular therapy products. We have clinicians working side-by-side with scientists, manufacturing staff and QA staff in our state-of-the art clean cell facility. And, we have assembled an extraordinary panel of advisors across many disciplines to aid in fulfilling our mission. Our capabilities range from immunomonitoring of patient samples to manufacturing of cellular products for immunotherapy.

Overview

Our experienced team is available to provide services to investigators to:

• produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current cGMP standards as required by federal regulations
• serve as a regulatory resource to MUSC in the preparation of cell and gene-therapy based INDs
• facilitate clinical development of novel cellular therapies

Resources at a Glance: Immunomonitoring & Other Services

The CCT offers a variety of immunomonitoring services. Customizable services range from processing and storage of patient samples for clinical trials to processing and analyzing human samples for research purposes. Resources include:

• Reporting to regulatory agencies, sponsors, and IRB's of record.
• 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.
• Quality management, including quality assurance, quality control, and quality oversight committee.
• 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.

Learn More About Our Facility

The Foundation for the Accreditation of Cellular Therapy (FACT) recognizes MUSC as a Cellular Center that exceeds standards in patient care and laboratory practices. 

The Center for Cellular Therapy is located on the 2nd floor of the Clinical Sciences Building. The 1000 square foot state-of-the-art facility consists of three ISO14644-1 compliant cGMP clean room suites that are fully functional and independent allowing maximal usage. 

Equipment

• Class 5 biosafety cabinets
• Stackable CO2 incubators
• Floor and tabletop centrifuges
• Regulating water baths
• COBE 2991 processors
• CliniMACS® cell sorter
• WAVE bioreactor
• Inverted fluorescent microscopeIslet isolation box and shaker
• Accuri C6 flow cytometer
• Luminometer
• Vapor phase liquid nitrogen storage
• In house autoclave

CCT Support Activities

• Quality and Compliance Standard Operating Procedure Development
• Operations, Quality and Materials Management
• Clinical Trial Budget Preparation
• IND Preparation
• Equipment Management
• Document Control
• Process Development
• Qualification/Validation

Contact Us

Center for Cellular Therapy
cellular-therapy@musc.edu 

Medical Director

Prabhakar Baliga, M.D.
baligap@musc.edu 

Scientific Directors

Shikhar Mehrotra, Ph.D.
mehrotr@musc.edu

Hongjun Wang, Ph.D.
wangho@musc.edu

QA Director

Tara Duke
duket@musc.edu