Interleukin 2 maintains biologic stability and sterility over prolonged time

The FDA approved interleukin 2 (IL2) fur clinical use in 1992 in a high-dos e bolus intravenous infusion schedule. IL2 administered by continuous low- and intermediate-dose infusion can result in a variety of immunologic effec ts including the expansion of thr Natural Killer (NK) cell pool and immune reconstitution in immune-deficient hosts. These immune modifications are es sential for augmentation of both currently available and evolving immunothe rapies. The manufacturer's data indicate stability of the IL2 for a period of 6 days. This time frame is not practical for prolonged infusional scheme s necessitating frequent changes of drug depots. We tested the biologic sta bility and sterility of the commercially available recombinant IL2 preparat ion (aldesleukin: Proleukin, Chiron) under clinical conditions for up to 30 days. Our results confirm that IL2. retains its biologic activity and ster ility under these conditions for prolonged periods. This information will s implify IL? outpatient regimens, allowing for convenient intervals for drug depot renewal, leading to improved patient compliance and conserved health care expenditures. (C) 2000 Elsevier Science B.V. All rights reserved.