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Analytical Services - Biopharmaceutical Reference Standard Characterization and Product Stability TestingAnalytical Services - Biopharmaceutical Reference Standard Characterization and Product Stability Testing
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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
- Capillary Electrophoresis methods (CE, cIEF)
- Charge Profile
- Isoelectric Point
- UV Spectrometry
- pH
- Osmolality
- Karl Fischer
- SDS-PAGE
- Western Blot analysis
Contact an expert about your analytical needs.
Contact Us +44 (0)141 946 9999

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