How To Build Flexibility Into Your CGT Manufacturing Process While Maintaining Regulatory Compliance

With only 5% to 10% of the manufacturing capacity currently available to support the large-scale commercialization of cell and gene therapy (CGT) products, the industry faces a significant bottleneck. This shortfall presents a critical challenge for CGT innovators: how to rapidly scale production in a way that is both flexible and compliant with the rigorous standards that patient safety demands. Unlike traditional pharmaceuticals such as aspirin or statins, CGT products are highly personalized. They rely on a patient’s own cells as the starting material and must be processed and returned to the patient within days. This level of complexity requires manufacturers to embrace unprecedented adaptability while maintaining strict regulatory compliance. It’s not a matter of choosing between flexibility and compliance—they must coexist seamlessly.

To meet this challenge, CGT companies must rethink their manufacturing strategies, invest in scalable technologies, and build partnerships that support both innovation and quality assurance. The future of personalized medicine depends on it. Explore how your organization can scale CGT manufacturing without compromising compliance.