PeproTech ensures that all aspects of our quality management system - from management of raw materials and equipment to facilities maintenance (environmental monitoring), manufacturing processes, internal audits and inspection processes - are in compliance with relevant GMPs and all applicable regulatory and standards requirements.
We perform extensive quality control tests to verify that PeproGMP® Cytokines meet rigorous standards for purity, identity, safety, activity and consistency.
• N-terminal amino acid sequence analysis
• Molecular weight determination by mass spectrometry
• Reversed-phase HPLC analysis
• SDS-PAGE with Western blotting
• UV spectroscopy
• SDS-PAGE with Western blotting (if applicable)
• Residual E.coli DNA testing
• Sterility: beginning, middle and end processes
• Low endotoxin
• Specific activity determined by product-specific in vitro bioassay, against reference standard and (when applicable) against WHO standards
• Certificate of Analysis
• Certificate of Origin
• Safety Data Sheet (SDS)