Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostic products, has 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.

BIO-RAD is a trademark of Bio-Rad Laboratories, Inc. in certain jurisdictions. HUCAL and CYSDISPLAY are trademarks of MorphoSys AG.  

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About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With 70 years of focus on quality and customer service, our products advance the scientific discovery process and improve healthcare. Our customers are universities, research institutions, hospitals, biotechnology and pharmaceutical companies, as well as public health and commercial laboratories including food safety and environmental quality testing facilities. Based in Hercules, California, Bio-Rad has a global network of operations with approximately 7,900 employees worldwide and $2.9 billion in revenues in 2021.