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Supporting mRNA Development With Quantitative Expression Analysis

Wed, Apr 16, 2025 11:00 AM EDT{LOCAL_TZ}
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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 Attend:
  • Lab directors and managers
  • Senior scientists and staff scientists
Featured Speaker:

Shane Karnik
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.

Speaker's Email: shane.karnik@aliribio.com
Speaker's LinkedIn: https://www.linkedin.com/in/shane-karnik-5331a66/

For any technical questions please contact Jordan Ramesh: jramesh@mjhlifesciences.com