🧬 As oligonucleotides grow complex, separating them from impurities is crucial for safety and compliance.
🔬 An improved two-step purification process, AX-IPRP, allows for high-resolution separation without special equipment.
💡 It achieves over 80% purity, simplifying integration into existing manufacturing systems.
❓ A Q&A session will follow the presentation for further insights.
Introduction:
The article discusses advancements in oligonucleotide purification methods, particularly focusing on new two-dimensional purification strategies that enhance the production and quality of oligonucleotide therapeutics. As the complexity of oligonucleotide products increases, efficient separation from impurities becomes critical for meeting purity standards and regulatory requirements.
- Challenges arise in purifying complex oligonucleotide sequences, necessitating innovative approaches to ensure product quality and regulatory compliance.
- The article introduces an enhanced purification process using a combination of strong anion exchange (AX) and ion-pair reversed-phase (IPRP) chromatography.
- This new AX-IPRP method is capable of achieving over 80% purity in long guide RNAs, facilitating effective separation with minimal complexity.
- Operational aspects for integrating these purification methods into current manufacturing frameworks, including considerations for resin selection and buffer control, are addressed.
- The insights shared during an upcoming webinar by Joe Guiles, PhD, will provide further understanding of the implementation and advantages of these purification techniques.
Conclusion:
The enhanced purification strategy discussed in this article presents a promising avenue for overcoming existing challenges in oligonucleotide manufacturing. By improving purity and simplifying the purification process through AX-IPRP chromatography, manufacturers can better meet regulatory demands and ensure the safety and efficacy of oligonucleotide therapeutics.