Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.

  title={Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.},
  author={G. Girija Shankar and Viswanath Devanarayan and Lakshmi Amaravadi and Yu Chen Barrett and Ronald R. Bowsher and Deborah L Finco-Kent and Michele Fiscella and Boris Gorovits and Susan Kirschner and Michael S. Moxness and Thomas G. Parish and Valerie E. Quarmby and Holly W. Smith and Wendell R. Smith and Linda A Zuckerman and Eugen Koren},
  journal={Journal of pharmaceutical and biomedical analysis},
  volume={48 5},
Most biological drug products elicit some level of anti-drug antibody (ADA) response. This antibody response can, in some cases, lead to potentially serious side effects and/or loss of efficacy. In humans, ADA often causes no detectable clinical effects, but in the instances of some therapeutic proteins these antibodies have been shown to cause a variety of clinical consequences ranging from relatively mild to serious adverse events. In nonclinical (preclinical) studies, ADA can affect drug… CONTINUE READING
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