Rituxan (rituximab)

Rituxan/Mabthera (rituximab) a chimeric human/murine monoclonal antibody targeted against the CD20 antigen expressed on the cell surface of B cells.  Therapeutically used in the treatment of haematological cancers (leukaemias and lymphomas) and autoimmune dysfunction (rheumatoid arthritis), Rituximab is described on the list of Essential Medicines important for a basic health system by the World Health Organisation.

Target Antigen: CD20

CD20 is a protein expressed on the surface of B cells, which in some lymphomas and leukemia’s are present in higher abundance than healthy individuals. Rituximab signals B-cells for depletion by targeting the CD20 antigen expressed on the cell surface, either by directly inducing target cell death or by utilizing the patient’s own immune system. 

Characterization of Rituximab Innovator and Biosimilar Products

Both the exact function of CD20 and the exact mechanisms of action of Rituxan (Rituximab) are not fully understood, however both Complement Dependent Cytotoxicity (CDC) and Antibody Dependent Cellular Cytoxicity (ADCC) are important mechanisms of action. The Fab-related functions of Rituxan (Rituximab) also cause inhibition of proliferation and induction of apoptosis when applied as a homodimer to CD20+ cell lines.

BioOutsource offers a comprehensive range of integrated services to support the biological, physicochemical and structural evaluation of Rituxan including characterization and comparability. Our off-the-shelf binding assays and bioassays include binding measurements for CD20 and the Fc-Receptors, C1q binding as well as the Rituxan Complement Dependent Cytotoxicity assay (CDC assay) and Rituxan Antibody Dependent Cellular Cytotoxicity assay (ADCC assay). In addition, we offer platform methods to assess the physicochemical properties and structural attributes of Rituximab innovator and biosimilar products.

BioOutsource also offers a range of generic testing and development services to support monoclonal antibody manufacture.

Contact our experts to discuss your Rituxan biosimilar testing needs.

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