title: Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.
abstract: All therapeutic proteins have the potential to induce anti-drug antibodies (ADA). Clinically relevant ADA can impact efficacy and/or safety of a biological therapeutic. Immunogenicity assessment strategy evaluates binding and neutralizing ADA, and the need for additional characterization (e.g., epitope, titer and so on) is determined using a risk-based approach. The choice of characterization assays depends on the type, application and immunogenicity of the therapeutic. ADA characterization can impact the interpretation of the risk profile of a given therapeutic, and offers insight into opportunities for risk mitigation and management. This article describes common ADA characterization methods. Strategic assessment and characterization of clinically relevant ADA are discussed, in order to support clinical options for safe and effective patient care and disease management.
authors.affiliation: Clinical Immunology, Amgen, Thousand Oaks, CA 91320, USA.
authors.forename: Suzanna M
authors.initials: SM
authors.lastname: Tatarewicz
authors.forename: Daniel T
authors.initials: DT
authors.lastname: Mytych
authors.forename: Marta Starcevic
authors.initials: MS
authors.lastname: Manning
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Swanson
authors.forename: Michael S
authors.initials: MS
authors.lastname: Moxness
authors.forename: Narendra
authors.initials: N
authors.lastname: Chirmule
mesh_terms: D000906:Antibodies / Q000276:immunology*; D000918:Antibody Specificity; D001688:Biological Products / Q000276:immunology*; D006801:Humans
chemical_list: D000906:Antibodies; D001688:Biological Products