According to regulatory guidelines, extensive analysis of a molecule is necessary to establish a well-characterized biologic or to demonstrate comparability between a biosimilar and reference product. Our skilled analytical chemistry staff has worked with a broad spectrum of molecules, including small molecules, peptides, lipids and glycoproteins.  

A range of analytical services are available in support of:

• Method development/transfer and validation
• Process and cleaning validation sample analysis
• Drug substance and drug product analysis
• Impurity analysis
• Stability testing
• Lot release testing
• Biosimilar testing

Testing Methods

• Amino acid composition analysis
• N-terminal sequencing
• SDS-PAGE
• IEF
• Western blot
• SEC-HPLC for aggregation analysis
• RP-HPLC for protein analysis
• Peptide mapping
• Monosaccharide composition
• N-linked oligosaccharide profiling
• Process residues (Tween, Triton™-X, Pluoronic®)
• Capillary electrophoresis
• IEX-HPLC
• Spectrophotometric assays
• Volumetric and coulometric water determination
• Visible/subvisible particulates
• Osmolality
• Optical rotation
• Head space analysis
• Sialic acid content of glycoproteins and total protein (BCA or Bradford microassays)
• Mass spectrometry

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