Navigating GMP Certification In Cell And Gene Therapy Manufacturing: The Digital Advantage

Cell and gene therapy (CGT) and advanced therapy medicinal product (ATMP) regulatory frameworks are not only intricate—they're in a state of constant evolution. Since 2017, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued a wave of new guidelines, reshaping the regulatory landscape at a rapid pace. This dynamic environment presents significant challenges for manufacturers, who must continuously adapt to stay compliant while maintaining efficiency. The complexity of these therapies goes far beyond regulatory documentation. As Rohin Krishnan Iyer, Senior Director of Cell and Gene Operations at Marken, points out, “With hundreds more cell and gene therapies in the clinical pipeline, a need for better process automation arises to enable scalable manufacturing, as well as cost and complexity reduction.” This is especially critical in the case of autologous therapies, where each patient's own cells form the basis of treatment.

Navigating this landscape demands more than awareness—it requires action. If you're involved in CGT development or manufacturing, now is the time to invest in smarter systems, scalable automation, and regulatory expertise. Explore how your organization can stay ahead in this rapidly evolving field.