Introduction
The Clinical Cell and Vaccine Production Facility (CVPF) was established as an NCI Core Grant Shared Resource of the University of Pennsylvania Abramson Cancer Center and a Clinical and Health Services Research Facility in the Department of Pathology and Laboratory Medicine of the Perelman School of Medicine. The Facility's main objective is to provide Penn Investigators and collaborators with access to technology and expertise in the scale-up, validation, and production of cellular products and biologics that would otherwise not be available to them individually. To facilitate translational research and meet the increasing demands for novel cellular therapy trials, the Facility needs to maximize resources (i.e., space and time for cell processing) so that its services are available to as many Investigators as possible. These user guidelines are intended to ensure that resources are allocated in an efficient and equitable manner by asking the users to assist in the prioritization of the Facility's pipeline of committed projects/trials.

Fees and Billing
A description of services and fees can be found on the PATH BioResource website at the following link: http://somapps.med.upenn.edu/pbr/cvpf/secure/fees.php.

All Investigators should review this page and consult with the Facility Director, Bruce Levine when putting together their budgets for proposed projects/trials so that an accurate assessment of Facility costs can be included in grant applications. Upon award, Investigators will be responsible for contacting Anne Chew, Director of Research Operations, to set up a user account so that monthly invoices for services performed can be billed to the Investigators designated funding source.

Access Policy
The Clinical Cell and Vaccine Production Facility will be available to all University Investigators. Priority access will be given to Cancer Center members with peer-reviewed funding or the equivalent (e.g., Clinical Trials Scientific Review and Monitoring Committee-approved clinical trials, Core Grant Developmental Funds pilot projects), followed by members without peer-reviewed funding. All Investigators will be required to meet with Dr. Levine at the start of study design and protocol development. This will ensure that the Facility is an appropriate venue for the proposed research, that the project design incorporates the efficient use of the Facility, and that the costly resources of the Facility are used for the greatest scientific benefit. In addition, Investigators are required to submit a Project Initiation Form. Prioritization of projects will be determined in consultation with the Advisory Committee as additional trials are proposed and will be based upon scientific merit, technical feasibility, Cancer Center membership, and the availability of external funding and the resource requirements of the core.

Project/Trial Scheduling
The Project Initiation Form is to be submitted to the CVPF a minimum of three months prior to the anticipated start of the trial or a minimum of six months prior to the anticipated start of a gene therapy trial if additional validation and development work is needed. The Facility Director will inform Investigators of project/trial scheduling within current capacity. In times of limited resources, scheduling priority will be given to Investigators with secured project funding. If funding is pending at the time of User Request Form submission, it is the responsibility of the Investigators to inform the Facility Director of funding award so that their respective project/trial can be re-prioritized. It is also the responsibility of the Investigators to inform the Facility Director of any delays in project/trial start-up so that resources can be rescheduled accordingly. Failure to do so may result in unavailable resources should there be scheduling conflicts with already committed projects/trials when the Investigators project/trial is in fact ready to start.

Patient Scheduling
Due to multiple ongoing trials and validation studies in the CVPF, Investigators are to inform all study staff that patient and donor eligibility must be confirmed with Elizabeth Veloso, Director of the Clinical Trials Unit. Subsequently, collection and infusion dates are to be scheduled with Ms. Veloso via e-mail and CC’ed to Zoe Zheng, Technical Director, and Bruce Levine, Facility Director. Dates provided may be tentative depending on patient or donor screening/testing or until staff and processing room availability can be confirmed. Pending confirmation from Elizabeth Veloso, Zoe Zheng, or Bruce Levine and appropriate documentation, collection of patient or donor cells may proceed.