HANDLING OF GENE-TRANSFER PRODUCTS BY THE NATIONAL-INSTITUTES-OF-HEALTH CLINICAL-CENTER PHARMACY-DEPARTMENT

Policies and procedures for handling gene-transfer products at the Nat ional Institutes of Health (NIH) Clinical Center pharmacy department a re described. The pharmacy at the Clinical Center is responsible for h andling in vivo gene-transfer delivery systems, which are gene-transfe r products that are prepared for direct administration to patients. Th e gene-transfer products currently handled by the pharmacy are investi gational and are composed of viruses containing the gene encoding eith er of the melanoma antigens MART-1 and gp100. The pharmacy has prepare d guidelines, based on the principles of aseptic technique and FDA gui delines for manufacturing facilities, intended to help pharmacy person nel safely dilute a concentrated gene-transfer product into a dose sui table for administration. Before a product is handled, the biological safety level is determined and a biohazard sign is posted. Worksheets detailing all supplies, calculations for dilutions, and procedures tha t will be required are prepared in advance; the worksheets are part of a drug fact sheet prepared for all investigational drugs dispensed. P ersonnel must be properly trained and dressed in protective clothing. Aseptic technique and decontamination procedures are used as specified in the guidelines, and all materials used are disposed of as biohazar dous waste. All work is documented. If a worker is accidentally expose d, standard procedures are followed. The handling of gene-transfer pro ducts at the NIH Clinical Center pharmacy is based on the principles o f aseptic technique, FDA guide lines, and experience.