Chemist US Food and Drug Administration Silver Spring, Maryland
Presentation Description: Because of the complexity of manufacturing and characterization of biotherapeutics, advanced bioanalytics are crucial to demonstrate the product's continued identity, quality and product performance. While the bioanalysis of biotherapeutics historically was the realm of ligand-binding assays (LBA), LC-MS/MS is developing into a widely accepted procedure when used in combination with immunoaffinity capture (hybrid LBA LC-MS/MS) techniques. This presentation will highlight the regulatory requirements for the bioanalysis of biotherapeutics and give an overview on the most important trends in hybrid LBA LC-MS/MS as emerging analytical technologies. Most importantly, the presentation will discuss how the learned experience of the scientific community for the bioanalysis of small molecules can help address analytical challenges of biotherapeutics due to their complex structure, in vivo protein-protein interaction, biotransformation and the occurrence of isoforms.
understand the workflow for regulated bioanalysis for large molecules
understand how the Office of Testing and Research develops bioanalytical methods
understand the recent progress on hybrid LBA LC-MS/MS