Bio-Rad has 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 anti-eculizumab antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support drug and biosimilar development and patient monitoring.
The new range is comprised of four inhibitory antibodies that are highly specific for eculizumab, the humanized IgG2/4 kappa monoclonal antibody drug, used to treat two very rare diseases.
The anti-eculizumab inhibitory antibodies can be used to quantify the level of eculizumab in patient samples and in bioanalytical assays for biosimilar development. An antibody pair is also 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.
Amanda Turner, Bio-Rad Product Manager of the Life Science Group, said: “Our unique anti-eculizumab antibodies are well characterised 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 new range was generated using the Human Combinatorial Antibody Library 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.