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Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents.

AAPS J. 2012; 
O'HaraDenise M,TheobaldValerie,EganAdrienne Clements,UsanskyJoel,KrishnaMurli,TerWeeJulie,MaiaMauricio,SpriggsFrank P,KenneyJohn,SafaviAfshin,KeefeJean
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Catalog Antibody … behavior in formulation, and other factors. “For therapeutic antibodies, our goal is always to make sure the antibody is 'fit for purpose,'” says Liusong Yin, Ph.D., director of antibody services, GenScript. “We need to characterize the … Get A Quote

摘要

Critical reagents are essential components of ligand binding assays (LBAs) and are utilized throughout the process of drug discovery, development, and post-marketing monitoring. Successful lifecycle management of LBA critical reagents minimizes assay performance problems caused by declining reagent activity and can mitigate the risk of delays during preclinical and clinical studies. Proactive reagent management assures adequate supply. It also assures that the quality of critical reagents is appropriate and consistent for the intended LBA use throughout all stages of the drug development process. This manuscript summarizes the key considerations for the generation, production, characterization, qualif... More

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