Regulated Bioanalysis Using High Resolution LC-MS: Headache or Opportunity?

E-Separation Solutions

The six presentations offered Wednesday afternoon will examine regulated bioanalysis using LC-MS and the resulting opportunities, including HRMS for drug discovery, QTOF for quantification purposes, pharmacokinetic sample analysis, accurate mass LC-MS, and HRMS phospholipid quantitation.

The six presentations offered Wednesday afternoon will examine regulated bioanalysis using LC-MS and the resulting opportunities, including HRMS for drug discovery, QTOF for quantification purposes, pharmacokinetic sample analysis, accurate mass LC-MS, and HRMS phospholipid quantitation.

Gary Schultz, of Advion Bioanalytical Labs, a Quintiles Company, Ithaca, New York, will be the first presenter, with a talk titled “Overview of Regulatory Guidelines and How High Resolution and Mass Accuracy MS Data Fulfill the Requirements.” Schultz will showcase improved precision and comparable selectivity and sensitivity for bioanalytical LC-MS with HRAM-MS compared with TQMS.

Louis-Phillippe Morin, of Algorithme Pharma Inc., Laval, Canada, will follow Schultz, with a presentation of “Thorough and Practical Evaluation of the Use of QTOF in High Throughput Regulated Bioanalysis: Performance, Robustness and Return on Investment.” Morin will examine questions about the production of reliable data overtime, the performance justifying the extra expense for a bioanalytical laboratory, and the amount of data generated (file size) affecting the data processing throughput.

The next presentation will be given by Panos Hatsis, of Novartis, Cambridge Massachusetts. Hatsis’ talk, titled “Quantitative Pharmacokinetic Sample Analysis and Metabolite Identification of Buspirone using High Resolution Accurate Mass Spectrometry,” will examine routine pharmacokinetic sample analysis with concurrent metabolite analysis of UHPLC samples using a Q Exactive HR/AM mass spectrometer.

Following Hatsis, Chunang (Christine) Gu, of Genentech, South San Francisco, California, will present “Quantitative Analysis of Potential Genotoxic Impurities by High Resolution Mass Spectrometer.” Gu will discuss an LC-MS method using a bench-top high-resolution mass spectrometer developed to quantify trace-level impurities in the final APIs.

Presenting next will be Robert Plumb, of Waters, Milford, Massachusetts. Plumb will give a talk titled “Accurate Mass MS-MS an Attractive Option for the Quantification of Biotherapeutics in DMPK Studies” in which the application of accurate mass MS for quantification in DMPK will be examined.

The final presentation will be “Evaluation of Resolving Power and Extraction Window with Comparison of Profile and Centroid Modes for High-Resolution Mass Spectrometry Phospholipid Quantitation,” given by Mingkun Fu, of Millennium: the Takeda Oncology Company, Cambridge, Massachusetts. Fu will discuss the utility of liquid chromatography coupled with full-scan high-resolution accurate mass spectrometry for untargeted quantitation as an alternative methodology to the tandem mass spectrometry quantitation.