SPL Set ID: f3c516ad-d405-4fbe-af6a-962080dbfa7d

Aldesleukin is a human interleukin-2 lymphocyte growth factor produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. It is a purified protein with a molecular weight of approximately 15,300 Da. This recombinant form differs from native interleukin-2 in the following ways: a) aldesleukin is not glycosylated; b) the molecule has no N-terminal alanine; c) the molecule has serine substituted for cysteine at amino acid position 125. Proleukin exists as biologically active, non-covalently bound microaggregates with an average size of 27 recombinant interleukin-2 molecules; the aggregation state of aldesleukin may differ compared to native interleukin-2. The manufacturing process for aldesleukin involves fermentation in a defined medium containing tetracycline hydrochloride. The presence of tetracycline hydrochloride is not detectable in the final product. Proleukin (aldesleukin) for injection is a sterile, preservative-free white to off-white, lyophilized powder, which has a cake-like appearance, supplied in single-dose vials for intravenous administration after reconstitution and dilution. When reconstituted with 1.2 mL Sterile Water for Injection, USP, each mL contains 18 million International Units (1.1 mg) aldesleukin, mannitol (50 mg), sodium dodecyl sulfate (0.19 mg), buffered with disodium hydrogen phosphate dihydrate (1.12 mg) and sodium dihydrogen phosphate dihydrate (0.19 mg) to a pH of 7.5 (range 7.2 to 7.8).