TITLE:
Effect of Excipients on Recombinant Interleukin-2 Stability in Aqueous Buffers
AUTHORS:
A. S. Prakasha Gowda, Andrew D. Schaefer, Terry K. Schuck
KEYWORDS:
Interleukin-2, Excipients, Stability, RP-HPLC, SDS-PAGE
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.12 No.10,
October
29,
2021
ABSTRACT: In order to retain structural and functional integrity, protein medicines are frequently stabilized with excipients in aqueous solutions. The goal of this investigation was to see how stable IL-2 is with excipients that are acceptable for cell therapy. We investigated the time-dependent stability of commercially available recombinant IL-2 in aqueous solutions (CTS, RPMI, PBS, and water) at different temperatures [2°C - 8°C, room temperature (20°C ± 2°C) and 37°C] in the presence of excipients (EDTA, methionine, histidine, and glycine) over a period of up to 30 days. To detect and quantify IL-2, reversed phase high performance liquid chromatography was employed. Electrophoresis on a sodium dodecyl sulfate polyacrylamide gel was used to assess conformational stability. We discovered that IL-2 stability was improved in aqueous solutions including excipients, and that it may have retained its biological activity and sterility in these conditions.