cGMP rHu IL-2 CSS

cGMP rHu IL-2 CSS

cGMP rHu IL-2 CSS

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rHu IL-2 outfitted for closed-system manufacturing.
See why everyone is choosing Akron cytokines.

Akron’s Recombinant Human Interleukin-2 (rHu IL-2) Closed System Solutions™ (CSS) is manufactured following all relevant cGMP guidelines for ancillary materials. The rHu IL-2 active substance is supported by a Type II Master File (MF) on file with the FDA and an MF Type I on file with Health Canada, which can be referenced during your drug or biologic application process.

Our rHu IL-2 amino acid sequence is identical to Proleukin® (aldesleukin), and its functional similarity in T Cell expansion has been evaluated and confirmed. Akron’s rHu IL-2 is a single chain, 15.3 kDa, non-glycosylated lymphokine analog expressed in E. coli, containing 133 amino acids. The downstream purification process uses a multi-step orthogonal approach, without the use of affinity tags, to minimize exogenous impurities and ensure the delivery of highly purified and active substance for further manufacturing applications.

The liquid rHu IL-2 CSS product is packaged in a sterile fluoropolymer bag with two different weldable tubing connection options, allowing for easy incorporation into modern closed-system cell culture bioprocessing protocols. rHu IL-2 CSS increases safety and ease of use by eliminating the reconstitution step during manufacture and allows for the introduction of cytokine material into culture media in a fully contained manner to maximize sterility. Sterile filtration and aseptic filling are followed by Endotoxin and Sterility testing performed per USP/EP on the final product. See product Packaging features below.

IL-2 plays a major role in both upregulating and downregulating the body’s immune response. It is critical for the homeostasis and differentiation of many immune cell types and is involved in the immune system’s ability for self-tolerance. The pleiotropic nature of cytokines is especially diverse in IL-2 due to its signal being transduced by at least three different primary signaling pathways. The trimeric IL-2 receptor protein (IL-2R) shares an identical subunit with the IL-7, IL-15, and IL-21 receptor proteins and activates some of the same signal transduction mechanisms. Akron’s cGMP-compliant rHu IL-2 can be used to promote the activation and proliferation of numerous immune cell types, including CAR-T cells, TCR-T cells, Tregs, TILs, NK cells, CIK cells, B cells, monocytes, and macrophages.

Akron rHu IL-2 vs Proleukin® – pSTAT5 Expressio3

Akron IL-2 functionality

Proleukin IL-2 functionality

 

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.