Post by Genedata

The FDA just published a draft guidance on the use of NGS for gene therapy products incorporating genome editing — with direct implications for CMC and manufacturing teams.   The guidance recognizes NGS as essential for off-target assessment and genomic integrity evaluation, and outlines how validated strategies can support development programs.   The draft is open for comment, making it critical to review and engage. If your team is advancing NGS in QC, this is a key opportunity to shape the framework.   At Genedata, we enable a broad range of NGS-based QC assays within integrated platforms, helping ensure the safety and quality of gene-edited therapies in line with evolving regulatory expectations.   Read more here: https://lnkd.in/djrGuyVE