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Analytical Services - Biopharmaceutical Reference Standard Characterization and Product Stability Testing

Analytical Services - Biopharmaceutical Reference Standard Characterization and Product Stability Testing

Contact Us

Phone

+44 (0)141 946 9999

Tel +44 (0)141 946 9999

Email

info@bioreliance.com

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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.

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