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.

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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.

Recent Videos

Alternative Modes of Liquid Chromatography for Oligonucleotides

PFAS and Fluorinated Compounds: Considering Potential Future Restrictions

On-Column Structural Formations

Robustness and Reproducibility: Is There a Competency Crisis?

Future Perspectives and Fit-For-Purpose Separation Power

Discussing Analytical Strategies and 2DLC

Chemistries and Products Available for ASOs

Challenges in Analyzing Antisense Oligonucleotides (ASOs)

Introducing the Panel: The State of The Art in Oligonucleotide Analysis