cGMP rHu TNF-α Lyophilized
High quality cGMP materials.
See why everyone is choosing Akron cytokines.
Akron’s Recombinant Human Tumor Necrosis Factor-alpha (rHu TNF-α) product is manufactured following all relevant cGMP guidelines for ancillary materials. Akron’s rHu TNF-α is a glycosylated cytokine analog expressed in yeast. Its active form is a homo-trimer with subunit molecular weights of approximately 17.4 kDa. The lyophilized product is packaged into vials and available in 25 µg and 50 µg aliquots.
In vivo, TNF-α is an endogenous pyrogen that can induce fever and apoptosis. There are both soluble and bound forms of TNF-α, and two different receptors which it signals through. This allows it to act in one of two opposite ways; it can be pro-inflammatory inducing apoptosis, or anti-inflammatory inducing proliferation. TNF-α is produced by a wide array of cell types in the body and causes a myriad of responses. Akron’s cGMP-compliant rHu TNF-α can be used to promote ex vivo responses from B cells, natural killer (NK) cells, neutrophils, hematopoietic stem cells (HSCs), hematopoietic progenitors, endothelial cells, and neurons
Manufacturing
• Yeast expression system
• Negligible BSE/TSE risk from all media components
• Low Endotoxin (< 1 EU/µg)
• High Purity (≥ 97%)
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 on cold packs
Reconstitution
Reconstitute the lyophilized product with 0.2 mL of sterile water. This reconstituted solution can be stored at 2 °C to 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. 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 (Non-Reducing SDS-PAGE)
• Purity (Reducing SDS-PAGE)
• Bacterial Endotoxins
Aliquot Sizes & Formats
Lyophilized (25 µg) Cat # AK9887-0025
Lyophilized (50 µg) Cat # AK9887-0050
