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Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
Published on: September 10, 2018
Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity
Francesca Civoli1, Mark A Kroenke, Kaz Reynhardt
1Department of Clinical Immunology, Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320, USA. fcivoli@amgen.com
The development of an unwanted immune response to a protein therapeutic is a constant concern and necessitates careful monitoring of this class of drugs during clinical development. Neutralizing antibodies can have a significant impact on bioavailability, efficacy and safety of a protein therapeutic. Consequently, immunogenicity testing is required prior to obtaining regulatory approval and in some cases even after a product is marketed. Given the importance of this testing, it is critical that sensitive and robust assays are developed for detection of clinically relevant neutralizing antibodies. This review will describe considerations and current best practices for developing assays to detect neutralizing antibodies to protein therapeutics.
The development of an unwanted immune response to a protein therapeutic is a constant concern and necessitates careful monitoring of this class of drugs during clinical development. Neutralizing antibodies can have a significant impact on bioavailability, efficacy and safety of a protein therapeutic. Consequently, immunogenicity testing is required prior to obtaining regulatory approval and in some cases even after a product is marketed. Given the importance of this testing, it is critical that sensitive and robust assays are developed for detection of clinically relevant neutralizing antibodies. This review will describe considerations and current best practices for developing assays to detect neutralizing antibodies to protein therapeutics.
