Interleukin 2 maintains biologic stability and sterility over prolonged time.

Area of Science:

• Immunology
• Pharmacology
• Biochemistry

Background:

• Interleukin 2 (IL2) was FDA-approved in 1992 for high-dose bolus intravenous infusion.
• Continuous low- and intermediate-dose IL2 infusions induce immunologic effects like Natural Killer (NK) cell expansion and immune reconstitution.
• These immune modifications are crucial for enhancing current and future immunotherapies.

Purpose of the Study:

• To assess the biologic stability and sterility of commercially available recombinant IL2 (aldesleukin) under clinical conditions for extended durations.
• To determine if IL2 can be reliably used in prolonged outpatient infusional schemes beyond the manufacturer's recommended 6-day stability period.

Main Methods:

• The study evaluated the biologic stability and sterility of aldesleukin (Proleukin, Chiron) under clinical conditions.
• The preparation was tested for stability and sterility over a period of up to 30 days.

Main Results:

• The results demonstrate that IL2 retains its biologic activity and sterility for up to 30 days under the tested clinical conditions.
• This extended stability is significantly longer than the manufacturer's indicated 6-day period.

Conclusions:

• Commercially available recombinant IL2 (aldesleukin) is stable and sterile for prolonged periods (up to 30 days) under clinical conditions.
• This extended stability simplifies outpatient IL2 regimens, allowing for less frequent drug depot changes.
• These findings can lead to improved patient compliance and reduced healthcare costs.