Biosimilars

With yearly patent expiry of therapeutic proteins the market for biosimilars is still growing at high pace. As provider of a broad range of state of the art analytical techniques we are also specialized in conducting comparability studies for biosimilar development. We cover the structural as well as the functional characterization of proteins allowing us to provide you with a complete analytical package for your biosimilarity study. This includes

We have broad experience in biosimilar projects which includes a wide selection of the currently developed molecules on the market.

  • Adalimuman (Humira®)
  • Aflibercept (Eylea®)
  • Alglucosidase alfa (Myozyme®)
  • Bevacizumab (Avastin®)
  • Cetuximab (Erbitux®)
  • Daratumumab (Darzalex®)
  • Denosumab (Prolia®)
  • Eculizumab (Soliris®)
  • Erythropoietin (EPO)
  • Etanercept (Enbrel®)
  • Filgrastim (Neupogen®)
  • Galsulfase (Naglazyme®)
  • Golimumab (Simponi®)
  • Idurosulfatase (Elaprase®)
  • Infliximab (Remicade®)
  • Insulin (Lantus®)
  • Laronidase (Aldurazyme®)
  • Mepolizumab (Nucala®)
  • Pertuzumab (Perjeta®)
  • Ranibizumab (Lucentis®)
  • Rituximab (Rituxan®)
  • Tocilizumab (RoActemra®)
  • Trastuzumab (Herceptin®)
  • Ustekinumab (Stelara®)

Our portfolio includes in depth analysis of the protein primary structure, amino acid modifications, as well as charge and size heterogeneity. We are specialists in determining protein glycosylation structures, which are among the most important protein modifications that can have significant influence on function and stability of biopharmaceutical molecules.

Our vast experience and deep knowledge in this field allows us to guide you through the variety of available methods and help you find the optimal analytical solution for your project.

  • Verification of amino acid sequence by LC-MS
  • Quantitative analysis of N- & C-terminal modification or truncation by LC-MS
  • Amino acid content after protein hydrolysis by LC-UV incl. determination of extinction coefficient
  • Peptide mapping by LC-ESI-MS/MS
  • Peptide mapping by RP-UV
  • N- and C-terminal sequencing by MALDI-TOF
  • N-terminal sequencing by Edman (partner laboratory)
  • Lysine clipping analysis of mAB by LC-MS or CEX-UV
  • Molecular weight determination by LC-ESI-TOF
  • Molecular weight determination by MALDI-TOF

  • Site specific analysis of acetylation, cysteinylation, deamidation, glycation, isomerization, N- and O-glycosylation, oxidation, PEGylation, phosphorylation, sulfation, etc.
  • Accessible by multi attribute methods (MAM) such as peptide mapping with LC-ESI-MS/MS or intact mass analysis by LC-ESI-MS or MALDI-MS

  • Access to galactosylation, sialylation, mannosylation, afucosylation, bisecting GlcNAc, alpha-galactose, presence of O-glycosylation, etc. by the following methods
  • Intact mass or molecular weight determination by LC-ESI-TOF
  • Glycopeptide analysis by LC-ESI-MS/MS
  • Analysis of released N- and O-glycan by HILIC-FLD-MS, MALDI-TOF, and HPAEC-PAD
  • Monosaccharide analysis by HPAEC-PAD
  • Sialic acid analysis by HPAEC-PAD
  • Glycan linkage analysis by GC-MS

  • Access to amidation, deamidation, glycation, isomerization, lysine clipping at C-terminus, oxidation, pyroglutamate, or protein fragments
  • Ion exchange chromatography (IEX-UV)
  • Cation exchange chromatography coupled to mass spectrometry (CEX-MS)
  • Isoelectric focusing (IEF)
  • Capillary isoelectric focusing (cIEF) incl. determination of pI
  • Capillary zone electrophoresis (CZE)

  • Access to protein fragments, level of impurities, and aggregation
  • Size exclusion chromatography (SEC-UV)
  • Size exclusion chromatography coupled to mass spectrometry (SEC-UV-MS)
  • Capillary gel electrophoresis (CGE) / capillary electrophoresis sodium dodecyl sulfate (CE-SDS)
  • (2D-)SDS-PAGE

  • Disulfide linkage analysis by LC-ESI-MS/MS
  • Analysis of free thiol groups by fluorescence measurement (Ellman´s assay)
  • Circular dichroism
  • Differential scanning calorimetry
  • Fourier-transform infrared (FTIR) spectroscopy
  • Protein stability by fluorescence measurement

  • Binding and kinetic assays using surface plasmon resonance (SPR)
  • Enzyme-linked immunosorbent assays (ELISA)
  • Cell based bioassays
  • Further potency assays

Get in contact and learn more about our analytical capabilities.