Characterisation of biopharmaceuticals

Health authorities demand extensive state-of-the-art characterisation studies for the approval of biopharmaceuticals. This is specified by in the ICH Q6B and other relevant guidelines. In this field we are recognized as a reliable partner.

Mass spectrometry plays a central role in the characterisation of protein and nucleic acid-based active substances, as it provides detailed structural information. We have experience with mass spectrometric investigations of biomolecules using both, intact (top down) and enzymatically digested (bottom up) approaches. Together, both analytical approaches provide a comprehensive picture of the structure of a biomolecule and its microheterogeneity.

We offer the analysis of intact biomolecules using high-resolution ToF mass spectrometers, while we use high-resolution orbitrap technology for peptide mass mapping (peptide mass fingerprinting).

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Identification of unknowns
Quantification of impurities