title: Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
abstract: The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major importance for their successful development and licensure. Antibodies elicited by these products in many cases cause no detectable clinical effects in humans. However, antibodies to some therapeutic proteins have been shown to cause a variety of clinical consequences ranging from relatively mild to serious adverse events. In addition, antibodies can affect drug efficacy. In non-clinical studies, anti-drug antibodies (ADA) can complicate interpretation of the toxicity, pharmacokinetic (PK) and pharmacodynamic (PD) data. Therefore, it is important to develop testing strategies that provide valid assessments of antibody responses in both non-clinical and clinical studies. This document provides recommendations for antibody testing strategies stemming from the experience of contributing authors. The recommendations are intended to foster a more unified approach to antibody testing across the biopharmaceutical industry. The strategies proposed are also expected to contribute to better understanding of antibody responses and to further advance immunogenicity evaluation.
authors.affiliation: Bioanalytical R&D, Abbott Vascular Inc., Santa Clara, CA 95054, USA. eugen.koren@av.abbott.com
authors.forename: Eugen
authors.initials: E
authors.lastname: Koren
authors.forename: Holly W
authors.initials: HW
authors.lastname: Smith
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Shores
authors.forename: Gopi
authors.initials: G
authors.lastname: Shankar
authors.forename: Deborah
authors.initials: D
authors.lastname: Finco-Kent
authors.forename: Bonita
authors.initials: B
authors.lastname: Rup
authors.forename: Yu-Chen
authors.initials: YC
authors.lastname: Barrett
authors.forename: Viswanath
authors.initials: V
authors.lastname: Devanarayan
authors.forename: Boris
authors.initials: B
authors.lastname: Gorovits
authors.forename: Shalini
authors.initials: S
authors.lastname: Gupta
authors.forename: Thomas
authors.initials: T
authors.lastname: Parish
authors.forename: Valerie
authors.initials: V
authors.lastname: Quarmby
authors.forename: Michael
authors.initials: M
authors.lastname: Moxness
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Swanson
authors.forename: Gary
authors.initials: G
authors.lastname: Taniguchi
authors.forename: Linda A
authors.initials: LA
authors.lastname: Zuckerman
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Stebbins
authors.forename: Anthony
authors.initials: A
authors.lastname: Mire-Sluis
mesh_terms: D000818:Animals; D000906:Antibodies / Q000032:analysis*; D001688:Biological Products / Q000276:immunology*; D001709:Biotechnology / Q000379:methods*; D006801:Humans; D018570:Risk Assessment
chemical_list: D000906:Antibodies; D001688:Biological Products