Meeting FDA Guidelines for CRISPR sgRNA Purity with Orthogonal Chromatography

Join Agilent’s expert to explore a novel purification method for CRISPR single guide RNAs (sgRNA). This GMP-proven approach achieves over 80% full-length purity, confirmed by high-resolution HPLC methods, and meets new regulatory standards. Recent FDA guidelines emphasise the need for 80% purity for full-length sgRNA products.

Although some CDMOs claim higher purity levels for CRISPR sgRNA, an analysis of their methods' resolving power may reveal lower purity levels.

Agilent addresses these requirements with an orthogonal chromatography approach using two modes of separation. This method, featuring Agilent’s PLRP-S purification resin and strong anion exchange purification, achieves over 80% purity for gRNAs greater than 100 nucleotides in length. This technique has been successfully translated into GMP production.

Gain a comprehensive understanding of the FDA CBER guidance for CRISPR sgRNA purity, learn how to leverage the resolution power of analytical chromatography methods for quality comparison, and discover Agilent’s optimised oligonucleotide synthesis and orthogonal chromatography approach.

What you will gain from this webinar:

• Understand FDA CBER guidance for 80% purity levels for full-length sgRNA products
• Learn how the resolution power of analytical chromatography methods allows for quality comparison
• Discover how Agilent’s optimised oligonucleotide synthesis and orthogonal chromatography approach reliably achieve 80% purity

Webinar Programme (CET time zone):

• 15.00 Welcome and introduction by Karen O'Hanlon Cohrt PhD., Editor-in-chief, CRISPR Medicine News
• 15.05 Amanda Haas B.S. / Business Development Manager, Agilent Technologies, United States
• 15.40 Q & A with Amanda Haas
• 15.55 Close by CRISPR Medicine News

Speaker | Title:

Amanda Haas B.S. / Business Development Manager, Agilent Technologies, United States | Meeting FDA Guidelines for CRISPR sgRNA Purity with Orthogonal Chromatography

_{Meet Amanda Haas and Agilent at the 2nd CRISPR Medicine Conference, CRISPRMED25 in Copenhagen, April 8-11, 2025.}