The VCTL has the expertise and experience in the preparation and manufacturing of cell-based vaccines such dendritic cell vaccines and viral vectors for Phase I and II investigator-initiated and pharmaceutical-sponsored clinical trials.
The VCTL is available to assist investigators in the following:
- process and assay development
- process and assay qualification
- cGMP manufacturing
The VCTL also provides investigators with regulatory support in the following:
- writing clinical trial-specific Standard Operating Procedures (SOP)
- writing IND Chemistry, Manufacturing, and Controls (CMC) documentation
- validation of manufacturing process
- participation in discussions with the FDA
The VCTL is supported by a dedicated and independent Quality Assurance Specialist who ensures adherence to applicable regulatory requirements and cGMP standards for manufacturing quality including facilities, equipment, personnel training, and work performance. The QA Specialist conducts audits, inspection, and reviews and reports any issues to the Director of the VCTL.
The adjacent QC laboratory has the capacity to perform in-process testing of cell-based therapy products including sterility, endotoxin, mycoplasma, identity by flow cytometry, and potency by cytokine secretion, proliferation, or activation of antigen-specific T cell responses. In addition, the laboratory coordinates submission of samples to qualified clinical testing laboratories.