New Software Tools for Impurity Analysis of Synthetic Oligonucleotides
Wednesday, September 7, 1:15-1:45 pm ET
Oligonucleotide therapeutics have emerged in recent years as a powerful alternative to small molecule and protein therapeutics. Manufacturing and quality control of oligonucleotide therapeutics requires highly selective and sensitive LC-MS methods. This presentation will highlight two recently introduced software applications: one used for purity analysis and rapid intact mass confirmation of oligonucleotide impurities, the second one for fast data interpretation of complex oligonucleotide fragmentation spectra. These two applications are embedded in an automated, compliance-ready LC-MS workflow designed for analysis of synthetic oligonucleotides and their impurities.
Speaker: Catalin Doneanu, Ph.D., Waters
Cytokine Analysis in Non-Clinical Studies: Thoughts on ability to relate cytokine findings to adverse toxicology findings
Wednesday, September 14 1:15 pm – 1:45 pm
This eChalk talk will explore the possibilities and challenges in the analysis and interpretation of multiplex cytokine data in the context of non-clinical safety studies. The focus of the discussion will be on strategies to improve the application of multiplex analysis to obtain a better understanding of adverse immune events or immunotoxicity in non-clinical models.
Speaker: John Farmer, Ph.D., Lovelace Biomedical
Increasing the Productivity of Oligonucleotide Purification through Column Scaling and Method Optimization
Wednesday, September 21, 2022 1:15-1:45pm ET
Isolation of purified oligonucleotides in an efficient, cost-effective manner can be extremely challenging. Reverse-Phase UPLC using an ion-pairing system of HFIP-TEA has become the gold standard for oligonucleotide analysis. This column and mobile system capitalize on the benefits of small columns particles, along with the unique ion-pairing properties using HFIP. The result is a rapid efficient method to accurately assess oligonucleotide’s purity.
The process of scaling an oligonucleotide separation using a UPLC method with a HFIP-TEA ion pairing buffer to preparative scale using a 3 cm ID column will be discussed. The components of each step of the process will be systematically evaluated to understand the impact of its variation and its impact on the overall process. The different items tested and varied include mobile buffers, mass and volume column loading and fraction collection.
Speaker: Paul Lefebvre, Averica Discovery Services