Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
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.
Koren
Eugen
E
Bioanalytical R&D, Abbott Vascular Inc., Santa Clara, CA 95054, USA. eugen.koren@av.abbott.com
Smith
Holly W
HW
Shores
Elizabeth
E
Shankar
Gopi
G
Finco-Kent
Deborah
D
Rup
Bonita
B
Barrett
Yu-Chen
YC
Devanarayan
Viswanath
V
Gorovits
Boris
B
Gupta
Shalini
S
Parish
Thomas
T
Quarmby
Valerie
V
Moxness
Michael
M
Swanson
Steven J
SJ
Taniguchi
Gary
G
Zuckerman
Linda A
LA
Stebbins
Christopher C
CC
Mire-Sluis
Anthony
A
D000818:Animals; D000906:Antibodies / Q000032:analysis*; D001688:Biological Products / Q000276:immunology*; D001709:Biotechnology / Q000379:methods*; D006801:Humans; D018570:Risk Assessment
D000906:Antibodies; D001688:Biological Products