HERCULES, Calif.–February 7, 2019–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced the launch of a range of recombinant monoclonal anti-idiotypic antibodies that inhibit the binding of eculizumab (Soliris) to its target, complement C5 protein. These anti-eculizumab antibodies detect free drug and are designed for use in drug level monitoring assays and biosimilar development.
The new range of recombinant monoclonal anti-idiotypic antibodies is comprised of four inhibitory antibodies that are highly specific for the humanized IgG2/4 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 they may also be used in bioanalytical assays for biosimilar development. An antibody pair is suitable for the development of a pharmacokinetic (PK) bridging ELISA, and antibodies of high, medium, and low affinity can be used as a positive control or calibrator in an anti-drug antibody assay.
The recombinant monoclonal anti-idiotypic antibodies are generated using the Human Combinatorial Antibody Library (HuCAL®) and CysDisplay®, a proprietary method of phage display with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply.
“Bio-Rad’s portfolio of highly specific anti-biotherapeutic antibodies continues to expand, providing critical reagents for use in preclinical and clinical development of biosimilars, and for therapeutic drug monitoring of patients,” said Amanda Turner, Bio-Rad Product Manager, Life Science Group. “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,” she added.
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.