HERCULES, Calif. — April 11, 2022 — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today introduced a range of antibodies that are specific to cemiplimab (Libtayo) and inhibit the binding of the drug to its target, human programmed death receptor-1 (PD-1). These ready-made antibodies are suitable for developing selective and sensitive assays for bioanalysis and drug monitoring of cemiplimab.
Cemiplimab acts as a checkpoint inhibitor by binding to PD-1 on T cells and blocking the interaction with its ligands, PD-L1 and PD-L2, thereby activating T cells to attack cancer cells. The new range of anti-cemiplimab antibodies offers optimal flexibility for bioanalytical ligand binding assays. Three fully human IgG1 antibodies with varying levels of affinity are ideal for use as surrogate positive controls or calibrators in anti-drug antibody assays. These are complemented by a TrailBlazer Antibody with a SpyTag2 incorporated into its heavy chain, which enables site-directed conjugation or fast conversion to a bivalent Fab or an Ig-like format within an hour. Using these antibodies, a highly sensitive pharmacokinetic bridging ELISA can be developed to measure free drug.
The recombinant antibodies are generated using the Human Combinatorial Antibody Libraries (HuCAL®) and CysDisplay®, a proprietary method of phage display, along with guided selection methods to obtain highly targeted reagents. The recombinant production method results in batch-to-batch consistency, ensuring reproducible results and a secure supply throughout the assay lifecycle.
“Bio-Rad’s portfolio of recombinant, monoclonal, anti-idiotypic antibodies continues to expand. These critical antibody reagents support researchers developing bioanalytical assays for checkpoint inhibitor drugs by providing sequence-defined, well-characterized reagents with stable supply,” said Amanda Turner, Bio-Rad Product Manager, Life Science Group. “The introduction of TrailBlazer Antibodies to the range brings added flexibility for bioanalytical assay design,” she said.
The anti-cemiplimab antibodies are approved for in vitro research purposes, and for commercial applications providing in vitro testing services to support preclinical and clinical drug and biosimilar development.
For more information about Bio-Rad’s anti-cemiplimab antibodies, please visit bio-rad-antibodies.com/anti-cemiplimab-antibody-libtayo.html
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 70 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology and pharmaceutical companies, 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 approximately 7,900 employees worldwide. Bio-Rad had revenues of $2.9 billion in 2021. For more information, please visit bio-rad.com.
This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding our expectations about our products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include the duration and severity of the COVID-19 pandemic, our ability to develop and market new or improved products, supply chain risks, our ability to compete effectively, international legal and regulatory risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad’s public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.
Media Contacts:
Bio-Rad Laboratories, Inc.
Kate Smith, Director, Global Customer Engagement Marketing
510-741-5307
kate_smith@bio-rad.com
Zyme Communications
Dr. Michelle Ricketts
+44 (0)778 9053 885
michelle.ricketts@zymecommunications.com