Equipment
The CPL consists of two "clean" rooms, one dedicated to gene transfer and selection of genetically-modified cells or culture of intrally-infected cells. The other is a cell culture facility and cell fractionation unit. The two rooms are connected by a pass-through and occupy about 600 square feet of space. The access to these rooms is restricted to the personnel engaged in the process of cell production (via card-controlled access). The floor surface and floor covering are designed to meet FDA specifications. The lab benches are stainless steel. The rooms are under positive pressure maintained by dedicated re-circulation air handling units. The pressure readings are taken continually by computer, and records are maintained in a data base (the direct digital control system (DDC)). The system alarms when malfunction occurs and notifies the emergency desk at the hospital. Each room has a vestibule for changing lab coats and washing hands. The laboratories are equipped with laminar flow hoods, incubators, centrifuges, microscopes, and all other equipment necessary for cell culture. Support services, such as tissue and body fluid procurement and processing, cell product cryopreservation, and phenotypic as well as functional characterization of the products, are performed in the main CPL laboratory.
The CPL is used exclusively for culture/processing of human cellular products for therapy. No animal cell cultures or any other cell products, except those prepared for therapy or cultures established from human cells sampled in the course of biologic therapies, are generated in this laboratory. The operational rules have been established for this laboratory such that only one patient's cells are handled at any given time, and each patient's cultures are incubated in a unique incubator chamber. The technologists are gowned and gloved when handling the cultures, and the access to the room is restricted to the personnel directly involved in cell production for therapy. All other operational guidelines follow the GMP requirements.
The CPL is inspected yearly by the College of American Pathologists and is prepared at all times for inspection by FDA. Yearly inspections by an independent certified auditor are conducted to satisfy the GMP guidelines.