The Regulatory Stance on Oligonucleotide Enantiomers
The panel dives into the regulatory stance on oligonucleotide enantiomers. The role of batch-to-batch reproducibility, new drug application (NDA) filing, and current guidelines are covered.
EP: 1.Introducing the Panel: The State of The Art in Oligonucleotide Analysis
EP: 2.Challenges in Analyzing Antisense Oligonucleotides (ASOs)
EP: 3.Chemistries and Products Available for ASOs
EP: 4.Discussing Analytical Strategies and 2DLC
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EP: 5.The Regulatory Stance on Oligonucleotide Enantiomers
EP: 6.Future Perspectives and Fit-For-Purpose Separation Power
EP: 7.Robustness and Reproducibility: Is There a Competency Crisis?
EP: 8.On-Column Structural Formations
EP: 9.PFAS and Fluorinated Compounds: Considering Potential Future Restrictions
EP: 10.Alternative Modes of Liquid Chromatography for Oligonucleotides
Regulatory guidelines must be considered when discussing oligonucleotide analysis and enantiomers. The panel reviews the current regulatory stance on this topic and common analytical bottlenecks relative to regulatory compliance.
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