In the past few decades, biotherapeutics have become a significant part of modern medicine. Bioanalytical assays are needed to support drug development and inform on the safety and efficacy of the candidate. Traditionally, ligand binding assays have been used to quantify the concentration of the drug candidates in biological fluid. LC-MS has emerged as another viable option for quantification of biotherapeutics. Validated methods are needed for analysis of PK samples from regulated studies. This presentation provides an update on bioanalytical method validation for biotherapeutics by mass spectrometry.
Evolution of the bioanalytical method validation guidelines by regulatory agencies.
History of Large molecule bioanalysis by mass spectrometry
Share industry experience activities with respect to bioanalysis of large molecules by mass spectrometry
Regulatory questions with respect to this technique
Preparation for a data driven meeting between the industry and regulators