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:
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:
- Levels of Pyroglutamination
- Disulfide bridges
- Heavy chain C-terminal Lysine
- Glycosylation (in particular, levels of galactosylation and fucosylation)
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BioPharmaSpec scientists have provided data to support many biosimilar development programs for our global client base. Contact our scientists now to understand how we can use our protein characterization methods to accelerate the development of your molecule.