Bio-Rad Laboratories Inc, Hercules, Calif, has launched a line of recombinant monoclonal antiidiotypic antibodies that inhibit the binding of eculizumab (Soliris) to its target, complement C5 protein. The anti-eculizumab antibodies detect free drug molecules and are designed for use in drug level monitoring assays and the development of biosimilars.
The new line of recombinant monoclonal antiidiotypic antibodies comprises four inhibitory antibodies that are highly specific for the humanized IgG 2/4 kappa monoclonal antibody drug eculizumab, a biotherapeutic that is used to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The anti-eculizumab inhibitory antibodies can be used to quantify the level of eculizumab in patient samples and may also be used in bioanalytical assays for biosimilar development. An antibody pair is suitable for the development of a pharmacokinetic (PK) bridging enzyme-linked immunosorbent assay (ELISA), and antibodies of high, medium, and low affinity can be used as a positive control or calibrator in an antidrug antibody assay.
The recombinant monoclonal antiidiotypic antibodies are generated using the human combinatorial antibody library and CysDisplay, a proprietary method of phage display with guided selection methods for obtaining highly targeted reagents. The recombinant production method also ensures a consistent and secure supply.
“Bio-Rad’s portfolio of highly specific antibiotherapeutic antibodies continues to expand, providing critical reagents for use in preclinical and clinical development of biosimilars, and for therapeutic drug monitoring of patients,” notes Amanda Turner, product manager in the life science group at Bio-Rad. “Our unique anti-eculizumab antibodies are well characterized and have been validated for use in PK and immunogenicity assays. Adding new specificities to our portfolio will help researchers overcome challenges associated with assay design and sensitivity.”
The anti-eculizumab antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring.
For further information, visit Bio-Rad Laboratories.
Featured image: Anti-eculizumab antibodies from Bio-Rad Laboratories.