Event Overview
After the first messenger RNA (mRNA)-based vaccines came to market with emergency use authorization a few years ago, many more mRNA drugs with indications beyond preventive care are in preclinical and clinical stages of development. Their unprecedented potential earned them Breakthrough Therapy and Fast Track designations by regulators.
Since the cellular machinery translates mRNA drug substance into proteins, multiple strategies can be pursued for quantitative assessment to support drug development. This presentation will discuss the pros and cons of different quantitative analytical approaches for mRNA pharmacokinetics/pharmacodynamics and bioanalysis studies. It will showcase method development strategies for protein expression analysis, including sample preparation, surrogate peptide selection, and assessment with liquid chromatography (LC) coupled to high-resolution mass spectrometry (HRMS). Further, the method transfers from HRMS to triple quadrupole technology will be discussed, and verification and validation criteria for regulated bioanalysis under good laboratory practices (GLP) will be presented.
Key Learning Objectives:
- Understand the existing quantitative approaches for mRNA expression analysis
- Learn how to approach method development from sample prep to MS setup and method transfer
- Evaluate a case study for method verification and validation
Who Should View:
- Lab directors and managers
- Senior scientists and staff scientists
What You Need to Know:
Format: On demand
Duration: 28 minutes
Presenter:
 | Shane Karnik Senior Laboratory Director, Aliri Bioanalysis Shane Karnik, MSc, serves as the senior laboratory director at Aliri Bioanalysis. He leads a team of bioanalytical scientists supporting non-GLP and GLP preclinical and clinical studies for a variety of biopharmaceutical drugs in development. Karnik has an MSc degree in chemistry from the University of Colorado and worked for several years in R&D and in the pharmaceutical industry before joining Aliri Bioanalysis in 2003. |
