Session Chair: Regina Olivera

Keynote Speaker: Rainer Bischoff, University of Groningen, The Netherlands

Challenges in Biopharmaceuticals and Biosimilars Analysis
Biopharmaceuticals have caused a paradigm shift in disease treatment and has led to an improvement in the quality of life of patients with chronic and autoimmune diseases. On-going analytical research has shown a remarkable shift from analysis of small to large molecules. In this rapidly-evolving field, there is a widespread need for analytical development and application of innovative technologies. Protein biopharmaceuticals are large and heterogeneous and their in-depth analysis during drug discovery and quality control requires extensive method development considering the best of both separation and detection.
Sensitive, accurate, and high-throughput analytical methods that deliver high-quality quantitative data for pharmacokinetic, pharmacodynamic, and toxicokinetic studies, are critically important to the development of these drugs. Historically, the bioanalysis of proteins and peptides has been performed using immunological-based techniques. However, continued improvements in CE-MS and LC-MS-based methodologies over the past years have generated assays with sufficient robustness and sensitivity to be applied to the quantitation and characterization of biomolecules.
This session will highlight analytical challenges and new technologies used for bioanalysis of protein and peptides-based therapeutics. Submissions addressing characterization and quantitative bioanalysis of biopharmaceutical and biosimilars are most welcome.