cGMP
rHu PDGF-AA Lyophilized
High quality cGMP materials.
See why everyone is choosing Akron growth factors.
Akron’s Recombinant Human Platelet Derived Growth Factor-AA (rHu PDGF-AA) product is manufactured following all relevant cGMP guidelines for ancillary materials. Akron’s rHu PDGF-AA is a dimeric, approximately 29 kDa, glycosylated growth factor analog expressed in Yeast. The lyophilized product is packaged into vials and available in 1 mg aliquots.
In vivo, PDGF-AA is part of the PDGF family, consisting of various dimers that have similar functions. PDGFs play an important role during embryonic development, stimulating and controlling the populations of mesenchymal stem cells (MSCs) and their progenitors. They have also been shown to affect osteogenic differentiation and proliferation of oligodendrocytes. PDGF functions have overlap with vascular endothelial growth factors (VEGFs) and epidermal growth factor (EGF). It has been used to study and develop technology in tissue regeneration and wound repair. Akron’s cGMP-compliant rHu PDGF-AA can be used to promote the ex vivo expansion of MSCs and various mesenchymal progenitor cells.
Active Substance
• Negligible BSE/TSE risk from all media components
• High Purity (≥ 97%)
Manufacturing
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
• Yeast expression system
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
• Currently under long-term stability program
• Store at -20 °C
• Transport with cold packs
Reconstitution
Reconstitute the lyophilized product in sterile water to a concentration of 0.1-1.0 mg/mL. Avoid multiple 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
• Protein Content (Quanti-it Protein Assay)
• Protein Content (Bradford Assay)
• Purity (Reducing SDS-PAGE)
• Purity (Non-Reducing SDS-PAGE)
• Biological Activity
Aliquot Sizes & Formats
Lyophilized (1 mg) Cat # AK9711-1000
