%0 Journal Article %1 Rup.2007 %A Rup, B. %A O'Hara, D. %D 2007 %J AAPS.J. %K Antibodies Binding Chemistry Immunoassay Indicators Ligands Monoclonal Pharmaceutical Pharmacokinetics Preparations Reagents Reproducibility Research Results Safety Sensitivity Specificity and metabolism methods of standards %N 2 %P E148-E155 %T Critical ligand binding reagent preparation/selection: when specificity depends on reagents %U PM:17614357 %V 9 %X Throughout the life cycle of biopharmaceutical products, bioanalytical support is provided using ligand binding assays to measure the drug product for pharmacokinetic, pharmacodynamic, and immunogenicity studies. The specificity and selectivity of these ligand binding assays are highly dependent on the ligand binding reagents. Thus the selection, characterization, and management processes for ligand binding reagents are crucial to successful assay development and application. This report describes process considerations for selection and characterization of ligand binding reagents that are integral parts of the different phases of assay development. Changes in expression, purification, modification, and storage of the ligand binding reagents may have a profound effect on the ligand binding assay performance. Thus long-term management of the critical ligand binding assay reagents is addressed including suggested characterization criteria that allow ligand binding reagents to be used in

@article{Rup.2007, abstract = {Throughout the life cycle of biopharmaceutical products, bioanalytical support is provided using ligand binding assays to measure the drug product for pharmacokinetic, pharmacodynamic, and immunogenicity studies. The specificity and selectivity of these ligand binding assays are highly dependent on the ligand binding reagents. Thus the selection, characterization, and management processes for ligand binding reagents are crucial to successful assay development and application. This report describes process considerations for selection and characterization of ligand binding reagents that are integral parts of the different phases of assay development. Changes in expression, purification, modification, and storage of the ligand binding reagents may have a profound effect on the ligand binding assay performance. Thus long-term management of the critical ligand binding assay reagents is addressed including suggested characterization criteria that allow ligand binding reagents to be used in }, added-at = {2010-02-05T11:28:39.000+0100}, author = {Rup, B. and O'Hara, D.}, biburl = {https://www.bibsonomy.org/bibtex/23ad8cb2d9d3d3a6e5ce0eb153e3ba5c7/kanefendt}, interhash = {3a604c02615152e7812314da765d5c3a}, intrahash = {3ad8cb2d9d3d3a6e5ce0eb153e3ba5c7}, journal = {AAPS.J.}, keywords = {Antibodies Binding Chemistry Immunoassay Indicators Ligands Monoclonal Pharmaceutical Pharmacokinetics Preparations Reagents Reproducibility Research Results Safety Sensitivity Specificity and metabolism methods of standards}, number = 2, pages = {E148-E155}, timestamp = {2010-02-05T11:28:54.000+0100}, title = {Critical ligand binding reagent preparation/selection: when specificity depends on reagents}, url = {PM:17614357}, volume = 9, year = 2007 }