Services
Click here for a full service list across all School of Medicine Research Cores
FDA Regulation and Cell Therapy Clinical Trial Consultation
- The cGMP Facility Director provides one–on–one consultations to investigators in planning
and conducting clinical trials and assisting in the preparation of Investigational New Drug
(IND) applications to the FDA. - Review of cell therapy product manufacturing process by core director
- Consultation for preIND data for IND application and standard operating procedures
(SOP) development - Review of Quality control and Quality Assurance services for clinical cell product
Monoclonal and Recombinant Bispecific Antibodies
- Generation and cryopreservation of a Master Cell Bank
- Quality control testing for a Master Cell Bank
- Validation and scale-up of research protocol to cGMP clinical process
- Production and purification of monoclonal antibodies from a specific clone
- Quality control testing of purified monoclonal antibody
- Production and purification of bispecific antibodies from a specific clone
- Quality control testing of purified bispecific antibody
- All support services are provided for viral vector production
The cGMP personnel has extensive experience in cell manipulation, growth, and transduction of lymphocytes and other immune cells. The cGMP core provides material processing, material modification, material production, material analysis, material maintenance, and material support services.
- Separation and cryopreservation of patient/donor PBMC from whole blood or bone marrow aspirate
- Monocyte depletion of pheresis product
- Cryopreservation of pheresis product
Manufacturing of cell-based therapies
- Activation and Expansion of T cells (ATC)
- Manufacture of Bispecific Antibody Armed ATC (BATs)
- Cryostorage of BATs
- Quality Control/Quality Assurance (QC/QA) of cell therapy product
- Activation of T cells
- Transduction of activated T cells with retroviral or lentiviral vector( Material processing service )
- Remove beads and wash cells
- Expansion of gene transduced cells
- Determination of viral copy number
- Cryostorage of BATs
- Quality Control/Quality Assurance (QC/QA) of cell therapy product
- Activation and Differentiation of Tregs
- Cryostorage of armed Tregs
- Quality Control/Quality Assurance (QC/QA) of cell therapy product
Quality Control (QC) Services
Before cell therapy product is infused in patients, the cells must be certified to be free of contaminating agents (sterility testing) and to meet the requirements for cell purity, phenotype, identity and potency.
We perform sterility testing for bacteria, fungi, mycoplasma, bacterial endotoxins either in our own QC laboratory (endotoxin), or at in UVA clinical laboratories (bacteria & fungi) or FDA approved offsite contract (Mycoplasma).
Quality testing of the cellular product includes cell viability, phenotyping and functionality of the product. The results from these assays are recorded on Quality Assurance Release Forms, Master Data Form and Certificate of Analysis forms prior to the release of cell therapy product for infusion in patients. Quality Control process is overseen and signed off by an independent Quality Assurance officer before the release of the product.
Consultation
We provide scientific, technical and regulatory support for investigator initiated investigational new drug applications (INDs) in cell and gene therapy. The Facility Director and staff provide one-on-one consultations to investigators for the preparation and submission of Investigational New Drug (IND) applications to the FDA. Review of cellular and biologic product manufacturing process and SOP development for clients. The Facility Director has prepared multiple requests for information from the FDA in the Chemistry, Manufacturing, and Controls section of an IND demonstrating her experience and expertise in CMC.
Education and Training Service
The Facility Scientific Director participates in Cancer Center’s seminars to spread the awareness about the cGMP facility at UVA Campus, and delivering webinars hosted by the biologic product related companies. CHT cGMP staff provide full training to new users.