cGMP rHu IL-12

cGMP IL-12 engineered and manufactured to enable the commercialization of NK-based therapeutics.

Akron’s Recombinant Human Interleukin-12 (rHu IL-12) products are manufactured following relevant cGMP guidelines for ancillary materials. Akron’s rHu IL-12 is a 75 kDa, glycosylated, heterogeneous dimer cytokine analog expressed in Yeast. The p40 chain contains 306 amino acids and the p35 chain contains 197 amino acids, for a total of 503 amino acids. The lyophilized product is packaged in vials.

Active Substance

• Negligible BSE/TSE risk from all media components
• Low Endotoxin (< 1 EU/μg)
• High Purity (≥ 97%)

Manufacturing

• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
• Yeast expression system
• Tag-free purification

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

• 36-month shelf life
• Store at -20 °C
• Transport with cold packs

Reconstitution

Reconstitute the lyophilized product with 0.2 mL of sterile water. This reconstituted solution can be stored at
2-8 °C for one month and at -20 °C for three months without loss of activity. Avoid repeated freeze-thaw
cycles.

For Use Statement

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

Certificate of Analysis (CoA)
TSE/BSE Statement
Certificate of Origin (CoO)
Safety Data Sheet (SDS)
Product Page

• Appearance
• Specific Activity
• Purity
• Bacterial Endotoxins

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.