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Antidrug Antibody Assay Validation: Industry Survey Results

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Abstract

Immunogenicity of biopharmaceutical products has attracted considerable attention from the industrial, academia, and regulatory organizations. Many methods exist to detect and characterize level of antidrug antibody response in patients. Still, additional work is required to harmonize various approaches used throughout the industry. This review presents results of a survey sponsored by the American Association of Pharmaceutical Scientists that was designed to collect relevant information and to understand various methods used throughout the bioanalytical field for the detection and evaluation of antidrug antibody responses.

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Abbreviations

AAPS:

American Association of Pharmaceutical Scientists

ADA:

antidrug antibody

ECL:

electrochemiluminescence

ELISA:

enzyme-linked immunosorbent assay

NC:

negative control

OD:

optical density

SD:

standard deviation

SPR:

surface plasmon resonance

References

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Acknowledgments

This survey was generated with the help of the American Association of Pharmaceutical Scientists (AAPS). The author particularly wants to thank Scott Didawick for tremendous help in programming and distributing of the survey. The author also wants to thank B. Rup and other members of the Wyeth bioanalytical group who provided many ideas and important critique during text review process. The survey results were initially presented at the National Biotechnology Meeting in Toronto, Canada (2008). The author thanks numerous attendees of the roundtable for their constructive feedback, which was generally incorporated into the final version of this manuscript.

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  1. Wyeth Research, 401 N Middletown Rd., Pearl River, New York, 10965, USA

    Boris Gorovits

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  1. Boris Gorovits
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Correspondence to Boris Gorovits.

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Gorovits, B. Antidrug Antibody Assay Validation: Industry Survey Results. AAPS J 11, 133–138 (2009). https://doi.org/10.1208/s12248-009-9091-6

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