Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, has announced the launch of a range of anti-certolizumab pegol inhibitory antibodies to support the development of assays for therapeutic drug monitoring of tumor necrosis factor (TNF) alpha inhibitors.

By extending its offering to include anti-certolizumab pegol antibodies, Bio-Rad offers critical reagents to support the development of anti-drug antibody (ADA) assays for all five marketed TNF alpha inhibitor biologics and their biosimilars.

The range of recombinant monoclonal anti-idiotypic antibodies comprises three antibodies that are highly specific for the monoclonal antibody Fab fragment certolizumab pegol (Cimzia) and inhibit the binding of this drug to its target: TNF alpha. The antibodies are fully human in full length IgG format and can be used as a surrogate positive control or calibration standard for an ADA assay to measure levels of patient anti-drug antibodies.

TNF alpha inhibitors are used to treat a wide range of inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and psoriasis. The levels of serum drug and ADA concentrations are monitored in patients receiving TNF alpha antagonists to help guide clinical decision making, optimize treatment, improve outcomes, and reduce healthcare costs.

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.

“Using a recombinant, human, monoclonal, anti-idiotypic antibody as a surrogate positive control overcomes the limitations of supply and batch variability imposed by an animal-derived antibody,” said Amanda Turner, Bio-Rad Product Manager, Life Science Group. “Having this critical antibody reagent available at the preclinical stage of development minimizes the need to revalidate assays with different reagents at the clinical development stage.”

The anti-certolizumab pegol 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.

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

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 a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,000 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019.