2017 White Paper on recent issues in bioanalysis : A global perspective on immunogenicity guidelines & biomarker assay performance (Part 3-LBA: Immunogenicity, biomarkers and PK assays)

The 2017 11th Workshop on Recent Issues in Bioanalysistook place in Los Angeles/Universal City, California, on 3–7 April 2017 with participation of close to 750 professionals from pharmaceutical/ biopharmaceuticalcompanies, biotechnology companies, contract research organizationsand regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule analysis involving LC–MS, hybrid ligand-binding assay(LBA)/LC–MS and LBA approaches. This 2017 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,...