cGMP rHu EGF Lyophilized
High quality cGMP materials.
See why everyone is choosing Akron growth factors.
Akron’s Recombinant Human Epidermal Growth Factor (rHu EGF) product is manufactured following all relevant cGMP guidelines for ancillary materials. Our rHu EGF, expressed in Yeast, contains three intramolecular disulfide bonds and 53 amino acids, with a molecular mass of approximately 5.9 kDa. It is purified in a pharmaceutical facility without the use of histidine tags and nickel columns. Sterile filtration, filling, and lyophilization are performed in-house with Endotoxin and Sterility testing performed per USP/EP on the final product. The lyophilized product is packaged in vials and available in 100 μg aliquots as listed above.
Manufacturing
• Yeast expression system
• Tag-free purification
• Negligible BSE/TSE risk from all components
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
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-months shelf life
• Store at -20 °C
• Transport on cold packs
Reconstitution
Reconstitute the lyophilized product in sterile water not less than 100 μg/mL.
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.
• Appearance (Visual)
• pH (Potentiometric)
• Purity (HPLC)
• Purity (Reducing SDS-PAGE)
• Purity (Non-Reducing SDS-PAGE)
• Specific Activity (MTT assay w/ Balb/c 3T3 cell line)
• Bacterial Endotoxin (LAL)
• Bioburden (USP <61> / EP 2.6.12)
Epidermal Growth Factor (EGF) is the prototype of the large family of EGF-like proteins which all share the three intramolecular disulfide bonds. EGF is a potent growth factor that stimulates the proliferation of various epidermal and epithelial cells. Additionally, EGF has been shown to inhibit gastric secretion, and to be involved in wound healing. EGF signals through a receptor known as c-erbB, which is a class I tyrosine kinase receptor. This receptor also binds with TGF-α and VGF (vaccinia virus growth factor). EGF stimulates the proliferation and differentiation of mesenchymal cells, acts as a mitogen for fibroblasts, epithelial and endothelial cells, and promotes colony formation of epidermal cells. Akron’s cGMP-compliant rHu EGF can be used to promote the activation and proliferation of fibroblasts and a number of other epithelial cells.
Aliquot Sizes & Formats
Lyophilized (100 μg) Cat # AK9797-0100
