Traditionally, LBA is the preferred bioanalytical technique for the quantification of therapeutic proteins. However, LC-MS has evolved as a reliable and complementary bioanalytical platform for the quantification of biotherapeutics. Typically, this is accomplished by affinity capture of therapeutic protein followed by enzymatic digestion into peptides and LC-MS/MS based quantification of signature peptide(s) as a surrogate readout for the therapeutic protein. LC-HRMS based quantitation and biotransformation assessment of intact protein biotherapeutics is increasingly being employed globally.
In this presentation, various case studies focusing on the application of LC-MS/MS and LC-HRMS methodologies for the quantification and biotransformation assessment of complex biotherapeutics including antibody drug conjugates, fusion proteins and pegylated proteins will be discussed.
Learning Objectives:
Upon Completion, participant will be able to understand the applications of LC-MS/MS for quantitation of complex biotherapeutics
Upon Completion, participant will be able to understand the applications of LC-HRMS and for quantitation and biotransformation assessment of complex biotherapeutics
Upon Completion, participant will be able to review various case studies focusing on LC-MS based bioanalysis of antibody drug conjugates, fusion proteins and pegylated proteins