title: Case studies from the use of commercial biomarker/protein test kits.
abstract: Large-molecule drugs (therapeutic proteins, peptides, various forms of antibodies) are more frequently being seen in drug-development pipelines, the majority of which are measured using immunochemical/ligand-binding techniques. The assays utilized for analysis of large-molecule drugs rely heavily upon the quality of the components (e.g., reference materials, antibodies) that are critical to the performance of the assays. Commercially available research-grade materials and kits offer a convenient and simple solution, but also present some unique challenges. This article will explore some examples of issues encountered while employing commercially available kits and reagents.
authors: PharmaNet Canada, Inc., 5160 boul. Décarie, Montréal, QC, H3X 2H9, Canada. cbeaver@pharmanet.com
authors: Chris J
authors: CJ
authors: Beaver
authors: Sarah K
authors: SK
authors: Roby-Peters
mesh_terms: D015415:Biomarkers / Q000032:analysis* / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D011786:Quality Control; D011933:Reagent Kits, Diagnostic
chemical_list: D015415:Biomarkers; D011933:Reagent Kits, Diagnostic