We have developed methods for the characterization and release testing of a wide range of biologics, including peptides, lipids, complex biologics, monoclonal antibodies, vaccines, AAV and lentiviral gene therapy products, glycoproteins, and nucleic acid-based products. In addition, we have extensive experience in analyzing small molecules present as residuals in formulated products and in challenging downstream purification matrices. To this end, we use a wide range of derivatization and detection methodologies when needed.

Many of our chromatographic methods are available as platform methods which can be simply performed “as is” on client samples. Methods are performed with state-of-the-art instrumentation and are available as a package or as individual services.

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    • N- & O-Linked Oligosaccharide Profiles
    • Sialic Acid Quantification
    • Monosaccharide Profile Analysis
    • SEC - Size / Aggregation Analysis
    • Purity, Identity, and/or Quantitation methods
    • Development of Stability-Indicating Methods
    • Residuals / Impurities / Degradants Analysis
    • Separation Technologies: RPC, SEC, HILIC, HIC, SAX, SCX, NP, WCX, WAX
    • Detectors: UV, VIS, DAD, CAD, ELSD, Fluorescence, Conductivity, PAD
    • Capillary Electrophoresis w/ LIF, UV/VIS
    • SDS-PAGE - Reducing / Non-Reducing
    • Isoelectric Focusing (IEF)
    • IPG Strips (immobilized pH gradient)
    • Densitometry
    • Immuno / Western Blotting
    • UV/VIS Absorbance
    • Fluorescence
    • Fourier-transformed Infrared
    • Circular dichroism