Bio-Rad Launches Anti-Evolocumab Antibodies

BP Elements, BioPharm International's BP Elements, September 2022, Volume 1, Issue 9

Bio-Rad’s new antibodies are designed to develop highly selective pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolocumab and its biosimilars.

Bio-Rad Laboratories recently introduced a range of type 1 antibodies that are designed to inhibit the binding of evolcumab to its target, human proprotein convertase subtilisin/kexin type 9 (PCSK9). These sequence-defined, recombinant antibodies are intended to develop highly selective and sensitive pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolcumab and its biosimilars.

Evolocumab is a monoclonal antibody (mAb) that has been used for the treatment of hyperlipidemia, or elevated levels of cholesterol and other lipoproteins. It binds to PCSK9, which, according to an Aug. 25, 2022 company press release, has been shown to play a key role in the regulation of cholesterol levels. By preventing the interaction between PCSK9 and low-density lipoprotein receptors, it intends to reduce circulating cholesterol and other lipoproteins.

This range of five anti-evolocumab antibodies includes fully human immunoglobulin G1 clones and recombinant human combinatorial antibody libraries antibodies with SpyTag (a technology for irreversible conjugation of recombinant proteins) technology incorporated into their heavy chain; this is designed to enable site-directed conjugation or fast-switching to a bivalent Fab or a full-length Ig-like format within an hour. The antibodies can also be used to develop PK bridging, enzyme-linked immunoassays to measure free drug or as a surrogate positive control or reference standard in an ADA assay.

"Bio-Rad's range of ready-made and well-characterized anti-idiotypic antibodies keeps growing, offering researchers enhanced flexibility for the development of custom bioanalytical drug assays against a wide range of marketed biologic drugs,' said Hilary Latham, marketing director, Life Science Group, Bio-Rad, in the press release. "Generated under stringent quality control for batch-to-batch consistency, these antibodies can produce translatable and reproducible results, ensuring assay reliability."

Source: Bio-Rad