Advancing quality standards for gene therapies: a USP perspective

“Our goal is to ensure that both large and small companies...have access to the analytical tools and reference standards needed for consistent, quality production.” In this interview, Abi Pinchbeck, Editor, BioInsights, speaks to Fouad Atouf, Senior Vice President, Global Biologics, US Pharmacopeia (USP), who provides insights into USP’s evolving role in supporting the cell and gene therapy industry. He discusses USP’s efforts to establish and refine standards to ensure the quality, safety, and efficacy of CGT products, in addition to the future of regulatory convergence in gene therapy development.