Protein characterisation

The medical authorities are nowadays demanding extensive protein characterisation studies, by state of the art methods, before granting market authorisation. The requirements are stated in the ICH guideline Q6B. We are a reliable partner in this field of analysis.

Mass spectrometry has become a valuable tool to characterise protein-based pharmaceuticals, because it delivers detailed structural information. We have elaborate experience in the analysis of intact proteins (top down) as well as the analysis after enzymatic protein digest (bottom up). Both approaches paint a reliable picture of the structure of a protein as well as its micro-heterogeneity. For intact measurement we apply high resolution ToF instruments, whereas the accurate mass orbital trap is utilised for the peptide mass map analysis. For many different aspects of protein characterisation, like the analysis of antibodies, we have developed generic methods and protocols. These are put into practice when performing complex comparability studies, which are compulsory for gaining market authorisation for biosimilars or demonstrating the effect of a process change on the product. Our specialists are looking forward to assist your projects:

  • Clone-Selection
  • Comparability studies after process change
  • Comparability studies for Biosimilars
  • Characterisation studies for IND und CMC