2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

The 2018 12th Workshop on Recent Issues in Bioanalysistook place in Philadelphia, PA, USA on April 9–13, 2018 with an attendance of over 900 representatives 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 bioanalysisinvolving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. This 2018 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 b...