Biomarker assay development and validation for large molecules in bioanalysis: what are the challenges and how are they overcome?

“..there is no substitute for experience, so as a community we must continue to commit to our collective education, regularly sharing our solutions, successes and failures through a variety of forums, providing a benefit to all.” ​‌Large-molecule biomarker assays used for regulated and exploratory purposes pose multiple challenges. From a practical perspective, even setting up the basic fundamentals of an assay, such as identification of standard reference material, selection of critical reagents and subsequent establishment of suitable assay controls, can prove daunting. Unlike for PK assays, a fundamental issue faced in large molecule biomarker assay development is that the purified...