Location: Live Webcast from San Francisco Bay Area

Speakers:

Luna Liu (Genentech), Mark Rose (Amgen), Doug Leipold (Genentech)

Details:

LC-MS/MS is increasingly being utilized for the quantification of biological therapeutic in study samples with high sensitivity, and offers an alternative platform to ligand-binding assays (LBAs) that have historically been used to determine protein drug levels in biological matrices. The goal of this workshop is to compare the two bioanalytical methods used in measuring biotherapeutics for pharmacokinetic (PK) analysis, illustrating through case studies the rationale for developing each type of assay, by providing examples of data collected to support validation and to address regulatory considerations, and by showing PK parameters to correlate data between the two methods measuring biotherapeutic drug levels.

Workshop Topics:

• Introduction to the use of liquid chromatography tandem mass spectrometry (LC-MS/MS) for quantitative protein bioanalysis as an alternative to ligand-binding assays (LBAs).
• Overview of LC-MS/MS assay development benefits and challenges, in comparison to LBAs
• Key considerations when validating an LC-MS/MS method for regulatory filings
• Role of LC-MS/MS platform in putting together a bioanalytical strategy for large molecules
• Case studies implementing LC-MS/MS for PK assays, for troubleshooting ELISAs, and for multiplexing
• PK parameters compared to assess the correlation between the two methods measuring drug levels in matrix, including C_max, AUC_tot, t_1/2, and any differences in results.