Equipped with high-resolution quadrupole Time-Of-Fly (TOF) mass analysers, coupled with a Ultra-High-Performance Liquid Chromatography (UPLC), various impurity characterisation can be done.

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Product Impurity Characterizations (LC-MS)

Peptide-based therapeutics can have high degrees of complexity for impurities that encompass sequence variants (including insertion or deletion) and degradation products, including oxidation, isomerization, and deamidation. A common approach is LC-UV, which is used to monitor impurities for small molecules, but it is unlikely to detect all impurities present. The use of LC-HRMS enables species to be quantified down to 0.1%, including for species that are not baseline-resolved from the main product peak.

Isoelectric Point

  • AEX-HPLC
  • cIEF
Amino acid analysis: We provide customized service in amino acid analysis. Waters ACQUITY UPLC® H-Class The AccQ
  • Tag Ultra Method is a precolumn derivatization technique for amino acids The UPLC AAA Solution, in combination with the AccQ
  • Tag Ultra Method, enables you to derivatize amino acids, separate the derivatives with reversed-phase UPLC, and quantitate the derivatives based on UV absorbance or fluorescence intensity.
Bioassays: Bioassay data that provide information on the potency of biological products are crucial at all stages in the development of biological products. These are essential for evaluating batch-to-batch consistency, product stability, comparability study and extended product characterization.. Consistent assay performance requires a controlled environment, skilled analysts with a thorough understanding of cell physiology and a well-developed/characterized method.

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