cGMP rHu GM-CSF Lyophilized
High quality cGMP materials.
See why everyone is choosing Akron growth factors.
Akron’s Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor (rHu GM-CSF) product is manufactured following all relevant cGMP guidelines for ancillary materials. Akron’s rHu GM-CSF is a single chain, approximately 15 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 150 μg aliquots.
Manufacturing
• No animal materials were used in the manufacture of this product
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
• E. coli expression system
• Endotoxin and Sterility per USP
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
Reconstitution
Reconstitute the lyophilized product with 1 mL of sterile water for injection (WFI).
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
• Biological Activity
• Molecular Weight
• Western Blot
• Host Cell Derived Protein
• Host Cell DNA
• Bacterial Endotoxins
• Sterility
In vivo, GM-CSF is produced by many cell types. It stimulates the development of neutrophils and macrophages and stimulates proliferation and development of megakaryocytic and eosinophilic progenitor cells. Akron’s cGMP-compliant rHu GM-CSF can be used to promote the ex vivo expansion of dendritic cells (DCs), hematopoietic stem cells (HSCs), and monocyctes.
Aliquot Sizes & Formats
Lyophilized (150 μg) Cat # AK8341-0150
