论文部分内容阅读
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.