BioPharmaSpec provides a complete solution for Rituximab/ Rituxan comparability, biosimilarity and characterization studies.
Rituximab (trade names Rituxan/ MabThera) is a chimeric monoclonal antibody made up of murine variable regions and a human IgG1 conserved region. It is targeted against CD20, a protein found mainly on the surface of B cells and will therefore destroy these cells. For this reason, Rituximab is used to treat diseases with high or unusual B cell populations, such as lymphomas, leukemias, transplant rejection, and autoimmune disorders.
Biosimilar Characterization Considerations
The guidelines state that Rituximab/ Rituxan comparability and 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
- Binding Assays – CD20, Fc-Receptors, C1q
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)
Need Biosimilar Testing?
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.