title: The integration of ligand binding and LC-MS-based assays into bioanalytical strategies for protein analysis.
abstract: Both LBAs and LC-MS-based assays are reviewed and summarized for applications in quantitative protein analysis. A strategy for platform selection is proposed based on several factors that contribute to the complexities of bioanalysis of biologics. Protein types, multiple co-existing forms, post-translational modifications, and affinities to ADA, targets, and endogenous proteins need to be considered when selecting the most appropriate platform. Other factors, such as intended use of data, assay sensitivity, available reagents, and multiple analytes also impact on the choice of bioanalytical platform. At BMS, strategies for the seamless integration of both platforms are being implemented to provide not only PK/PD data of the molecules but also useful information of the amino acid structure and functional relationship of the proteins.
authors.affiliation: Analytical and Bioanalytical Development, Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.
authors.forename: Yan J
authors.initials: YJ
authors.lastname: Zhang
authors.forename: Timothy V
authors.initials: TV
authors.lastname: Olah
authors.forename: Jianing
authors.initials: J
authors.lastname: Zeng
mesh_terms: D002846:Chromatography, Affinity; D002851:Chromatography, High Pressure Liquid; D004797:Enzyme-Linked Immunosorbent Assay; D047468:Immunoprecipitation; D020738:Leptin / Q000032:analysis / Q000493:pharmacokinetics; D008024:Ligands; D011506:Proteins / Q000032:analysis* / Q000302:isolation & purification / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry
chemical_list: D020738:Leptin; D008024:Ligands; D011506:Proteins