Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies.

@article{Geng2005ValidationOI,
  title={Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies.},
  author={Dong Geng and G. Girija Shankar and Allen Schantz and Manoj Rajadhyaksha and Hugh Davis and Carrie L Wagner},
  journal={Journal of pharmaceutical and biomedical analysis},
  year={2005},
  volume={39 3-4},
  pages={364-75}
}
Immunogenicity has always been an important consideration in the evaluation of pharmaceutical protein biologics. In this article, method validation parameters relevant to enzyme immunoassays are described for assays applied to the analysis of anti-drug antibodies, with special considerations for immunogenicity to therapeutic monoclonal antibodies. Common strategies for experimental investigation of various validation parameters are proposed. In addition, a novel, yet simple, approach is… CONTINUE READING