Product & Reference Standard Characterization

Reference Standard Characterization studies are used to determine the physiochemical profile of a drug substance or product in order to establish a standard for subsequent stages of testing. This testing is essential for characterising and analysing both original biologics and biosimilars. These studies often demand a broad variety of techniques and instrumentation for a complete analysis of drug purity, identity, and stability.

Our Reference Standard Characterization offering for recombinant proteins, monoclonal antibodies and biosimiars are cGMP compliant and are also offered for R&D purposes. We will work with you to design an analytical testing program customised to meet regulatory standards in the ICH guidelines:

• Mass Spectrometry methods
• Molecular Weight
• Peptide mapping
• Glycan Profiling
• N-Terminal Sequencing
• UHPLC methods
• Amino Acid Analysis
• Glycan Profiling
• SEC, IEX, RP chromatography
• Extinction Coefficient