title: Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity.
abstract: 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.
authors.affiliation: Department of Clinical Immunology, Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320, USA. fcivoli@amgen.com
authors.forename: Francesca
authors.initials: F
authors.lastname: Civoli
authors.forename: Mark A
authors.initials: MA
authors.lastname: Kroenke
authors.forename: Kaz
authors.initials: K
authors.lastname: Reynhardt
authors.forename: Yao
authors.initials: Y
authors.lastname: Zhuang
authors.forename: Arunan
authors.initials: A
authors.lastname: Kaliyaperumal
authors.forename: Shalini
authors.initials: S
authors.lastname: Gupta
mesh_terms: D000818:Animals; D057134:Antibodies, Neutralizing / Q000032:analysis* / Q000276:immunology*; D055808:Drug Discovery; D006801:Humans; D007109:Immunity; D007118:Immunoassay / Q000379:methods*; D011506:Proteins / Q000276:immunology* / Q000627:therapeutic use
chemical_list: D057134:Antibodies, Neutralizing; D011506:Proteins