Journal
JOURNAL OF IMMUNOLOGICAL METHODS
Volume 333, Issue 1-2, Pages 1-9Publisher
ELSEVIER
DOI: 10.1016/j.jim.2008.01.001
Keywords
immunogenicity testing; therapeutic proteins; risk assessment
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The appropriate evaluation of the immunogenicity of biopharmaccuticals 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. (C) 2008 Elsevier B.V. All rights reserved.
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