BioPharmaSpec provides a complete solution for Evolocumab/ Repatha comparability, biosimilarity and characterization studies.
Evolocumab (Trade name: Repatha®) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 ia a protein that targets LDL receptors for degradation, thereby reducing the liver’s ability to remove LDL-C from the blood. Repatha® is used to treat hyperlipidemia.
Biosimilar Characterization Considerations
The guidelines state that Evolocumab/ Repatha comparability and characterization should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:
Functional Testing by Custom Biologics
- Binding Assays
- Receptor Binding Assays
Product Specific Technical Considerations
Particular attention should be paid to the Post Translational Modifications (PTMs) including:
- Levels of Pyroglutamination
- Disulfide bridges and analysis of the various disulfide bridged isoforms
- 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.