HERCULES, CA — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader in life science research and clinical diagnostic products, introduced a range of type 1 antibodies that inhibit the binding of evolocumab (Repatha®) to its target, human proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that has been shown to play a key role in the regulation of cholesterol levels. These sequence-defined, recombinant antibodies are suitable for developing highly selective and sensitive pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolocumab and its biosimilars.
Evolocumab is a monoclonal antibody used for the treatment of hyperlipidemia, or elevated levels of cholesterol and other lipoproteins. It binds to PCSK9, preventing its interaction with low-density lipoprotein (LDL) receptors to reduce circulating cholesterol and other lipoproteins. The new range of five anti-evolocumab antibodies includes fully human IgG1 clones and TrailBlazer Antibodies with a SpyTag incorporated into their heavy chain, enabling site-directed conjugation or fast-switching to a bivalent Fab or a full-length Ig-like format within an hour. The antibodies can be used to develop PK bridging ELISAs 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, Bio-Rad Marketing Director, Life Science Group. “Generated under stringent quality control for batch-to-batch consistency, these antibodies can produce translatable and reproducible results, ensuring assay reliability.”
The recombinant antibodies are generated using the Human Combinatorial Antibody Library (HuCAL®) and CysDisplay®, a proprietary method of phage display, along with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply throughout the assay lifecycle.
The anti-evolocumab antibodies are approved for in vitro research purposes and for commercial in vitro testing services to support preclinical and clinical drug development.