cGMP rHu G-CSF Solution
High quality cGMP materials.
See why everyone is choosing Akron growth factors.
Akron’s Recombinant Human Granulocyte-Colony Stimulating Factor (rHu G-CSF) Solution product is manufactured following all relevant cGMP guidelines for ancillary materials. Akron’s rHu G-CSF is a single chain, approximately 18 kDa, non-glycosylated cytokine analog 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 sterile vials and available in 300 μg aliquots at a concentration of 300 μg/mL.
Active Substance
• No animal materials were used in the manufacture of this product
• High Purity (≥ 98%)
Manufacturing
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
• E. coli expression system
• Endotoxin and Sterility per USP/EP
Quality
• Relevant cGMP guidelines used in manufacture, testing, and release
• USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• EP 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal 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
• 24-month shelf life
• Store at 2-8 °C
• Transport on cold packs
• Avoid 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.
• Appearance
• pH
• Protein Concentration (HPLC)
• Biological Activity
• Molecular Weight
• Western Blot
• Purity (Non-Reducing SDS-PAGE)
• Purity (Reducing SDS-PAGE)
• Host Cell Derived Proteins
• Host Cell DNA
• Bacterial Endotoxins
• Sterility
In vivo, G-CSF stimulates the production of granulocytes and hematopoietic stem cells (HSCs) from bone marrow and stimulates the proliferation, differentiation, and activation of neutrophils. Akron’s cGMP compliant rHu G-CSF can be used to promote the ex vivo expansion of neutrophils and HSCs.
Aliquot Sizes & Formats
Liquid Vials (300 μg) Cat # AK8248-0300
