Support drug development strategies with mass spectrometry approaches for the bioanalytical analysis of oligonucleotide therapies
Learn how you decrease the method development required to obtain validated assays for regulatory evaluations of oligonucleotide therapeutics using high-resolution mass spectrometry (HRMS) in early-stage development.
Oligonucleotide therapeutics are increasing in drug development and regulatory submissions. These drugs have both bioanalytical extraction and analytical detection challenges arising from the chemical backbone or other stability-enhancing modifications of the drug. The utilization of HRMS in early-stage development can decrease the method development required to obtain validated assays for regulatory evaluations.
• Overview of different classes of oligonucleotide therapies
• Discuss the utility of mass spectrometry for oligonucleotide analysis
• Introduction to bioanalytical challenges and best practices for oligonucleotide analysis
• Case studies in the quantitation of oligonucleotide therapies using different mass spectrometry platforms
• Scientists or Lab Directors who support oligonucleotide therapeutic development or those looking to expand their knowledge of oligonucleotide bioanalysis
Speakers
Shane Karnik
Senior Laboratory Director
Aliri Bioanalysis (CO, USA)
Mr Karnik joined Aliri Bioanalysis in 2003. As the Senior Laboratory Director, his responsibilities include leading a team of bioanalytical scientists conducting bioanalytical projects that support pharmaceutical drug development for both non-GLP and GLP preclinical and clinical studies. These projects utilize state-of-the-art analytical techniques, including mass spectrometry, chromatography and automated sample preparation for the extraction and analysis of small molecule drugs, therapeutic peptides, therapeutic biologics and oligonucleotide drug candidates. In addition, Mr Karnik supports the technical and regulatory aspects of regulated studies conducted at Aliri Bioanalysis.
Before joining Aliri Bioanalysis, Mr Karnik earned a Master of Science in chemistry from the University of Colorado (CO, USA) in 2000 while working full-time in research and development at a medical device company. He then spent several more years in the pharmaceutical industry, where he developed and validated analytical methods for new drug submissions. Currently, Mr Karnik is an active member of the Bioanalytical CRO Council, AAPS bioanalytical focus groups and the American Society for Mass Spectrometry.
Troy Voelker, PhD
Director of Laboratory Operations
Aliri Bioanalysis (UT, USA)
Troy Voelker is the Director of Laboratory Operations at Aliri Bioanalysis in Salt Lake City where he leads all of the lab divisions including method development, method validation, instrument operations and production groups. He obtained his PhD in synthetic organic chemistry and a post doctorate in medicinal drug development and drug metabolism.
He has been working in the bioanalytical industry for over 17 years and has developed assays for large and small molecules with extensive experience on both triple quadrupoles and high-resolution accurate mass platforms. He is the Aliri subject matter expert for oligonucleotide bioanalysis in which he has led method development and validation for this therapeutic class for the past 10 years.
In association with
This webinar was recorded on the 9th of November 2023