Biologics Characterization

Eurofins Sinensis Biologics Characterization platform encompasses a comprehensive range of analytical R&D methods, including:

  • (U)HPLC-UV
  • Isoelectric focusing
  • Size-exclusion chromatography
  • Capillary electrophoresis
  • UPLC-QTOF
  • NMR
     

Peptide Mapping

We apply peptide mapping methods to fingerprint an individual protein and compare it with the standard reference or the theoretical gene-derived amino acid sequence. Peptide mapping can be used to assess product stability or consistency, ensure the identity of the protein and evaluate the presence of protein variants.

Post translational modification

Eurofins Sinensis routinely tests the profiles of therapeutic proteins and peptides and accomplishes full assignment of the profile for post translational modified protein drugs expressed in various hosts such as CHO.

We offer analysis of:

  • Glycosylation profile:
    • Total Mass
    • Glycosylation sites
    • Total glycan content
    • Structural elucidation of glycans
  • Phosphorylation profile
  • Ubiquitination
     

Biosimilarity demonstration

Eurofins Sinensis has supported the biosimilarity demonstration in several projects, for instance applying NMR fingerprinting methods, as well as the establishment and comparison of 3D-NMR biomolecular structures of originator and biosimilar products.

Contact our team of specialists for questions and requests about Biologics Characterization
and testing services:  Contact us here.


Questions? Call us now

+31 (0)24 240 3400