What's Unique about Ligand Binding Assay Bioanalysis and What Have We Learned from Outsourcing?

来源 :中国上海第七届国际新药发明科技年会 | 被引量 : 0次 | 上传用户:sanhaijin123
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  Ligand binding assays (LBA) are the primary methods used to quantify biotherapeutics,biomarkers and anti-drug antibodies in biologic matrices to support PK,TK and PK/PD studies throughout the life-cycle of biotherapeutics development.The necessity for these assays is growing as the increase of biotherapeutic proteins in development and the need ofbiomarker assays.While chromatographic assays are widely outsourced,LBA,however,have proven more difficult to outsource since they require specific considerations and present unique challenges for outsourcing.
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