GTAD Boston 2024—Gene Therapy Analytical Development Summit

Boston, MA, USA
October 30, 2024 – November 1, 2024

Meet Genedata experts at GTAD.

Don't miss out on the opportunity to see how Genedata solutions efficiently support the whole biopharmaceutical R&D workflow. Meet our collagues: David Killen, Qiu Ruan, and Ziwei (Coco) Li, and discover how Genedata Selector^®  enables biopharmaceutical organizations to make data-driven go/no-go decisions regarding gene therapy products safety, quality, and integrity. The platform supports biopharmaceutical companies to produce high-quality gene therapy products that meet both GMP requirements and regulatory standards, reducing both the time-to-market and development costs.

For more information about Genedata solutions or to set up a meeting, please contact us.

Recommended Posters

Leveraging NGS for Critical Quality Attribute Measurement of Gene Therapy Products

 David Killen¹, Thipa Asvarak¹, Sarah Berger², Thomas Hartsch^2
1Genedata Inc., US | ²Genedata AG, Switzerland

Available gene therapies have shown remarkable outcomes in treating various medical conditions. To ensure intended therapeutics are developed, in-process testing is required to maintain critical quality attributes (CQAs) like identity, integrity, and safety. Regulatory authorities such as the FDA and EMA request detailed CQA documentation for IND applications. A streamlined assay portfolio and technology that allows simultaneous determination of multiple attributes would be beneficial. Next-Generation Sequencing (NGS) is presented as a multi-attribute method for gene therapy products, streamlining multiple assays into one.

Genedata Selector Ensures GMP Compliance for Safe and Efficient Gene Therapy Development

Ziwei Li¹, David Killen¹, Qiu Ruan¹, Marcell Veidner², Thomas Hartsch^2
1Genedata Inc., US | ²Genedata AG, Switzerland

Next-generation sequencing (NGS) assays are revolutionizing the assessment of Critical Quality Attributes (CQA) and ensuring viral safety in biopharmaceutical companies, in line with ICH Q5A(R2) guidelines. While these assays generate vast amounts of valuable data, they also present computational challenges in data processing and management. Genedata Selector^® effectively addresses these challenges, meeting Good Manufacturing Practice (GMP) requirements, streamlining workflows, and supporting Computerized System Validation (CSV) projects. Additionally, it simplifies NGS biosafety workflows, ensuring reliable results and improved ROI.