Active Substance

• Carrier protein-free formulation
• Accurate mass and activity control
• High Purity via RP-HPLC (≥ 95%)

Manufacturing

• Multi-step downstream purification strategy excluding affinity tags
• Sterile microfiltration and aseptic filling/lyophilization
• Animal free expression system with yeast host

Quality

• Relevant cGMP guidelines used in manufacture, testing, and release
• USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered 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

Stability

• Under long-term stability
• Store at -20 °C
• Transport with cold packs

Reconstitution

Reconstitute the lyophilized product with sterile water to a concentration of 0.1 – 0.5 mg/mL. Avoid repeated freeze-thaw cycles.

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.

The dimeric nature of IL-12 is only shared by three other cytokines, all of which comprise the IL-12 family. In vivo, IL-12 is well known for stimulating the production of IFN-γ in T cells and Natural Killer (NK) cells. It also enhances the effectiveness of cytotoxic T cells and NK cells, helps generate lymphokine-activated killer (LAK) cells, and induces proliferation of activated T cells and NK cells. Akron’s cGMP-compliant rHu IL-12 can be used to help differentiate, proliferate, and stimulate helper T cells, cytotoxic T cells, NK cells, LAK cells, Dendritic Cells (DCs), and macrophages.