Aliquot Sizes & Formats

Liquid Syringe (500 µg) Cat. # AK9984-0500

Liquid Syringe (1 mg) Cat. # AK9984-1000

Protein Concentration (1 mg/mL)

Liquid CSS (1 MIU) Cat. # AR1045-0010 (10 μg/mL)

Active Substance

• Amino acid sequence identical to Proleukin® / aldesleukin
• Carrier protein-free formulation
• E. coli expression system
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)

Manufacturing

• Type II eCTD MF (#026152) on file with the FDA and MF Type I (#e250089) on file with Health Canada
• Tag-free pharmaceutical processing
• Gram-scale production capacity

Packaging

• Type I borosilicate glass syringe compliant per USP <660> Containers-Glass
• Luer-lock tip connector, for a tight seal and quick disconnect, compliant per USP <381> Elastomeric Closures for Injections
• Plunger stopper provides an effective barrier against extractables and leachables

Quality

• Relevant cGMP guidelines used in manufacture, testing, and release
• USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• EP 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
• ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
• ISO/TS 20399-1-3:2018, Biotechnology – Ancillary Materials Present During the Production of Cellular Therapeutic Products
• High Purity, Low Endotoxin – Endotoxin and Sterility testing per USP/EP

Stability

• 24-month shelf life
• Store at 2-8 °C
• Transport with cold packs

For Use Statement

For research use or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.

Akron rHu IL-2 vs Proleukin® – pSTAT5 Expression

Figure 1: To examine IL-2 signaling, freshly isolated PBMC from healthy donors were stained with surface antibodies targeting 21 different protein markers prior to in vitro stimulation with IL-2. Single mass cell cytometry was used to compare the effect of Akron’s rHu IL-2 (top) against Proleukin® (bottom) on the expression of pSTAT5, pSTAT3, & pSTAT1 in T cell subsets. (pSTAT5 example shown above).

When results were summarized for six healthy donors, T cell stimulation in vitro by Proleukin® and Akron rHu IL-2 were indistinguishable.

This study was done in collaboration with the Dana-Farber Cancer Institute; study and poster available upon request.