title: Ligand-binding assays: risk of using a platform supported by a single vendor.
abstract: The use of biological reagents in ligand-binding assays (LBAs) presents inherent challenges when measuring the concentration of large molecules in complex matrices. As a result, there are relatively few platforms that provide the accuracy, precision and robustness needed to determine the concentration of macromolecular therapies and biomarkers, and demonstrate the presence or absence of an immune response. Some bioanalytical laboratories use only one LBA platform to reduce costs, increase efficiency and maintain optimal assay performance. However, the business and regulatory risks of using a single platform supported by only one vendor should be considered. This article summarizes the immunological methods used to support bioanalysis for large molecules that are supported by a single vendor, the benefits of being dedicated to a single platform for bioanalysis used for regulatory filings, the costs associated with restructuring if an immunoassay platform is discontinued and recommendations to mitigate risk when using LBAs in drug development. The experience with the recent discontinuation of the BioVeris™ electrochemiluminescent-based platform is discussed.
authors.affiliation: Clinical Pharmacology Sciences, Centocor Research & Development, Inc., 200 Great Valley Parkway, Malvern, PA 19355, USA. jyohrlin@its.jnj.com
authors.forename: Jennifer
authors.initials: J
authors.lastname: Yohrling
mesh_terms: D015415:Biomarkers / Q000032:analysis; D015374:Biosensing Techniques / Q000295:instrumentation; D003132:Commerce / Q000295:instrumentation; D004563:Electrochemistry / Q000295:instrumentation; D005470:Fluorometry; D006801:Humans; D007118:Immunoassay / Q000191:economics / Q000295:instrumentation* / Q000379:methods*; D007202:Indicators and Reagents; D008024:Ligands; D049449:Luminescence; D046911:Macromolecular Substances; D010599:Pharmacokinetics; D015203:Reproducibility of Results
chemical_list: D015415:Biomarkers; D007202:Indicators and Reagents; D008024:Ligands; D046911:Macromolecular Substances