Akron’s Recombinant Human Basic Fibroblast Growth Factor-155 (rHu bFGF-155) product is manufactured following all relevant cGMP guidelines for ancillary materials. Our bFGF-155 is a single, non-glycosylated, polypeptide chain containing 155 amino acids and having a molecular mass of around 17.4 kDa, expressed in E. coli.
It is purified in a pharmaceutical facility without the use of histidine tags and nickel columns. Sterile filtration with aseptic 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.
• Expressed in E. coli
• Animal-derived component free
• Tag-free pharmaceutical biosimilar processing
• In-house sterile filtration with aseptic filling and lyophilization
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
• 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
• Currently on a long-term stability program
• Store at 2-8 °C
• Transport on cold packs
Reconstitute the lyophilized product with 1 mL of sterile water for injection (WFI)
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.
• Residual Moisture
• Protein Content
• Molecular Weight
• Specific Activity
• Biological Activity
• Bacterial Endotoxins
FGF2 plays a significant role in wound healing, it is a potent inducer of angiogenesis and it is essential for the growth of many stem and progenitor cells. It shares a 55% amino acid residue identity with FGF1 and interacts with heparin sulfate with nanomolar affinity. FGF2 is a potent inducer of DNA synthesis in a variety of cell types. Akron’s cGMP-compliant rHu FGF can be used to promote the activation and proliferation of hematopoietic progenitor cells, peripheral neuron cells, hepatocytes, and mesenchymal cells.
Lyophilized (100 μg) Cat # AK9784-0100