Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products |
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Authors: | Koren Eugen Smith Holly W Shores Elizabeth Shankar Gopi Finco-Kent Deborah Rup Bonita Barrett Yu-Chen Devanarayan Viswanath Gorovits Boris Gupta Shalini Parish Thomas Quarmby Valerie Moxness Michael Swanson Steven J Taniguchi Gary Zuckerman Linda A Stebbins Christopher C Mire-Sluis Anthony |
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Affiliation: | Bioanalytical R&D, Abbott Vascular Inc., Santa Clara, CA 95054, USA. eugen.koren@av.abbott.com |
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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. |
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