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Quality

GMP

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.

Identity and purity

• N-terminal amino acid sequence analysis

• Molecular weight determination by mass spectrometry

• Reversed-phase HPLC analysis

• SDS-PAGE with Western blotting

 

Protein Content

• UV spectroscopy

• SDS-PAGE with Western blotting (if applicable)

 

Safety

• Residual E.coli DNA testing

• Sterility: beginning, middle and end processes

• Low endotoxin

• Mycoplasma

 

Biological Activity

• Specific activity determined by product-specific in vitro bioassay, against reference standard and (when applicable) against WHO standards

Documentation

• Certificate of Analysis

• Certificate of Origin

• Safety Data Sheet (SDS)

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