2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

The 2015 9th Workshop on Recent Issues in Bioanalysis(9th WRIB) took place in Miami, Florida with participation of 600 professionals from pharmaceutical and biopharmaceuticalcompanies, biotechnology companies, contract research organizationsand regulatory agencies worldwide. WRIB was once again a 5 day, week-long event – A Full Immersion Bioanalytical Week – specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS and LBA approaches, including the focus on biomarkers and immunogenicity. This 2015 White Paperencompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better...