ClinGuide CRISPR sgRNA
Oligonucleotide GMP manufacturing for human therapeutics
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Agilent provides cGMP-compliant manufacturing services for single-guide RNA used in human therapeutics, offering high-purity, scalable, and regulatory-ready solutions to support clinical gene editing programs.
How to obtain high-purity sgRNAs for compliant CRISPR/Cas genome editing
Wednesday, June 25, 2025 at 16:00 BST / 17:00 CEST / 11:00 EDT / 8:00 PDT
CRISPR single guide RNAs (sgRNAs) are essential components of the CRISPR-Cas9 gene-editing system, serving as the navigational tool that directs the Cas9 enzyme to a specific target sequence in the genome. Each sgRNA is a short synthetic RNA composed of a scaffold sequence that binds to Cas9 and a custom-designed spacer sequence that defines the DNA target.
The accuracy and effectiveness of CRISPR-based editing depend heavily on the quality and integrity of the sgRNA. High-purity, full-length sgRNAs are crucial for minimizing off-target effects and ensuring consistent performance, particularly in clinical and Good Manufacturing Practice (GMP) settings where regulatory standards, such as those outlined by the FDA, demand rigorous quality control.
This webinar outlines a GMP-validated technique for purifying CRISPR sgRNAs that ensures over 80% full-length purity, as verified by high-resolution HPLC methods, and complies with the latest FDA standards.
Join our expert speakers to learn about this orthogonal chromatography approach from Agilent Technologies and to:
- Explore updated FDA CBER guidelines for CRISPR sgRNA purity and impurity detection levels.
- Learn about comprehensive analytics for sgRNA identity, purity and impurity analysis.
- Understand how combining strong anion exchange and reverse phase chromatography in orthogonal purification overcomes the limitations of single methods and achieves higher purity levels.
- Discover how high-resolution HPLC methods assess CRISPR sgRNA purity and ensure analytical comparability across various research and production stages.
- Gain insights into developing and qualifying dual purification processes, including using medium pressure equipment and optimizing buffer systems for high purity and step recovery.
Who should attend?
- External manufacturing, CMC, and supply chain managers overseeing CDMO partnerships and ensuring regulatory compliance.
- Analytical development and chemistry directors who are experts in transferring, developing, qualifying, and validating analytical methods for nucleic acid therapeutics.
- Technical leads, program managers, and leaders in developing and optimizing CRISPR technologies, gene editing, and RNA therapeutics.
- Quality assurance, quality control specialists, and professionals ensuring FDA compliance and maintaining high-purity standards in sgRNA production.
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes. If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
