BioPharmaSpec provides a complete solution for Trastuzumab/ Herceptin comparability, biosimilarity and characterization studies.

Trastuzumab (trade name Herceptin) is a standard IgG1 monoclonal antibody that binds to the HER2/ neu receptor. Due to this receptor being over-expressed in around 20% of breast cancers, Trastuzumab’s main use is to treat certain breast cancers.

Biosimilar Characterization Considerations

The guidelines state that Trastuzumab/ Herceptin comparability an characterization studies should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:

Structural Characterization

Physicochemical Characterization

Functional Testing by Custom Biologics

  • Antibody-Dependent Cell Cytotoxicity (ADCC) Reporter Bioassay
  • Complement-Dependent Cytotoxicity (CDC) Assay
  • Affinity Binding Assay
  • Proliferation Inhibition Assay

Product Specific Technical Considerations

Particular attention should be paid to the Post Translational Modifications (PTMs) including:

  1. Levels of Pyroglutamination
  2. Disulfide bridges
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular, levels of galactosylation and fucosylation)
  5. Deamidation
  6. Oxidation