The Clinical Cell and Vaccine Production Facility (CVPF) has extensive experience in cell manipulation, growth, and transduction of lymphocytes and other immune cells as well as adherent cell lines. This experience, and the quality controls established under a Quality Management Program, allows the Facility to quickly adapt new technologies to clinical trials.
The cell and processing services offered by the Facility include:
- Washing and cryopreservation of pheresis product
- Monocyte depletion of pheresis product
- Activation and expansion of donor or patient T lymphocytes
- Transduction of activated T cells with retroviral or lentiviral vector
- Generation of immature or mature dendritic cells
- Separation and cryopreservation of patient/donor PBMC from whole blood or bone marrow aspirate
- Conversion of patient or donor plasma to serum
- Generation and cryopreservation of a Master Cell Bank
- Quality control testing for a Master Cell Bank
- Conjugation of proteins or antibodies to magnetic beads and quality control
- Validation and scale-up of research protocol to clinical processes
The Facility Director and staff provide one-on-one consultations to investigators in planning and conducting clinical trials and assist in the preparation of grant applications to fund trials involving the core and for Investigational New Drug (IND) applications to the FDA. The Facility Director has demonstrated expertise in the Chemistry, Manufacturing, and Controls section of an IND and has prepared responses to multiple requests for information from the FDA.
Education and Training
The Facility Director participates in various retreats, meetings, and other events of the Cancer Center to create awareness of core services and to educate investigators on cellular engineering. He also conducts an introduction to quality and cellular engineering seminar periodically. Further, CVPF personnel obtain continuing education by participating in periodical webinars hosted by the International Society for Cell Therapy (ISCT).