Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

@article{Lee2011BioanalyticalAT,
  title={Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development},
  author={Jean Wenqing. Lee and Marian M. Kelley and Lindsay E. King and Jihong Yang and Hossein Salimi-Moosavi and M T Tang and Jian-feng Lu and John Kamerud and Ago B. Ahene and Heather A Myler and Cindy J Rogers},
  journal={The AAPS Journal},
  year={2011},
  volume={13},
  pages={99-110}
}
The predominant driver of bioanalysis in supporting drug development is the intended use of the data. Ligand-binding assays (LBA) are widely used for the analysis of protein biotherapeutics and target ligands (L) to support pharmacokinetics/pharmacodynamics (PK/PD) and safety assessments. For monoclonal antibody drugs (mAb), in particular, which non-covalently bind to L, multiple forms of mAb and L can exist in vivo, including free mAb, free L, and mono- and/or bivalent complexes of mAb and L… CONTINUE READING
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