Andelyn Biosciences and ENCell Announce Strategic Partnership to Expand Global Reach of Gene Therapy Manufacturing

Andelyn Biosciences, a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization ("CDMO"), and ENCell Co., Ltd, a Korea-based advanced biopharmaceutical CDMO, announced the signing of a Collaboration Agreement to establish a strategic manufacturing bridge between the United States and Asia-Pacific (APAC) regions to accelerate the global delivery of life-changing gene therapies.

The partnership leverages both companies' industry-leading GMP manufacturing facilities, technical expertise, and extensive regional networks to fast-track the development, manufacturing, and global expansion of client programs that deliver next-generation gene therapies to patients worldwide.

This partnership enables a streamlined 'dual hemisphere' workflow. By providing a direct route between US and APAC manufacturing hubs, the collaboration offers a simplified and cost-effective platform that removes the regulatory and logistical complexities of international expansion. Most importantly, facilitating in-country manufacturing for in-country clinical trials ensures regional supply chains can meet the specific needs of local patient populations, greatly reducing lead times and accelerating the path to commercialization.

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."

The partnership provides an opportunity to accelerate and expand patients' access to life-changing gene therapies, delivering on Andelyn's mission to bring more therapies to more patients.