Andelyn Biosciences, ENCell Enter Strategic Gene Therapy Manufacturing Pact   

Andelyn Biosciences, a cell and gene therapy CDMO, and ENCell Co., Ltd., a Korea-based biopharmaceutical CDMO, signed a collaboration agreement to establish a strategic manufacturing bridge between the U.S. and Asia-Pacific (APAC) regions to help accelerate the global delivery of gene therapies.

The partnership leverages both companies’ GMP manufacturing facilities, technical expertise, and extensive regional networks to help fast-track the development, manufacturing, and global expansion of client programs for gene therapies.

This partnership aims to enable a streamlined workflow by providing a direct route between U.S. and APAC manufacturing hubs and offers a simplified and more cost-effective platform that removes the regulatory and logistical complexities of international expansion. Additionally, facilitating in-country manufacturing for in-country clinical trials ensures regional supply chains can meet the specific needs of local patient populations, helping to reduce lead times and accelerate development.

Wade Macedone, CEO at Andelyn, said, “Our partnership with ENCell is a powerful step forward in Andelyn’s mission to help bring life-saving therapies to patients worldwide. By joining forces with such a respected leader in South Korea, we are not just expanding our global footprint; we are leveraging our unique strengths to deliver a truly seamless international manufacturing network. This collaboration reinforces our shared leadership in the cell and gene therapy space and ensures that, together, we can support our clients with the expertise and scale needed to deliver the next generation of medicines on a global stage.”

Dr. Jong Wook Chang, CEO of ENCell, said, “This partnership with Andelyn represents a significant step in expanding the global CGT ecosystem. By combining Andelyn’s expertise in viral vector development and cGMP manufacturing with ENCell’s clinical and manufacturing capabilities across APAC, we are establishing a seamless manufacturing platform connecting the United States and Asia-Pacific. Together, we will enable more efficient development and scalable production of gene therapies, supporting our clients from early-stage development through global clinical trials and commercialization.”