American Society of Gene + Cell Therapy 27th Annual Meeting
Baltimore, MD, USA
May 7–11, 2024
Join Genedata experts at the 27th Annual Meeting of ASGCT.
Don't miss the opportunity to see how Genedata Selector® enables biopharmaceutical organizations to make data-driven go/no-go decisions regarding cell and gene therapy products' safety, quality, and integrity with significant time savings. By providing out-of-the-box pipelines for automated NGS data analysis, Genedata Selector empowers scientists to implement biosafety testing in-house without the need for extensive bioinformatics training.
Recommended Poster Presentations
Leveraging NGS for Critical Quality Attribute Measurement of Gene Therapy Products
David Killen, Business Development, Genedata Selector, Boston, MA
Available gene therapies have had remarkable outcomes, yet there have been multiple cases where some therapeutics have led to unforeseen outcomes and clinical holds. To avoid that and guarantee that the intended therapeutics are developed, in-process testing is required to ensure these therapeutics maintain critical quality attributes (CQAs). For gene therapies, CQAs include identity, integrity, and safety.
Establishing and monitoring these attributes throughout development and manufacturing can help to ensure the product developed is safe and fit for its purpose. Regulatory authorities such as the FDA and the EMA also request detailed documentation regarding CQAs when companies apply for an IND. For this, a streamlined assay portfolio and the right technology that allows the simultaneous determination of multiple attributes of therapeutics would be highly beneficial.
Here we present Next-Generation Sequencing (NGS) as the multi-attribute method for gene therapy products, as it eliminates the need for implementing several different assays to determine CQAs by streamlining multiple assays. The vast amount of useful information obtained from NGS makes it easier, faster, and more cost-efficient to examine the critical quality attributes of gene therapy products.
For more information about Genedata solutions or to set up a meeting, please contact info(at)genedata.com.
