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.
About Andelyn Biosciences, Inc.
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization, and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 500 clinical batches and 80 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven AAV Curator® Platform or tech transfer in an established client program. Capabilities include cGMP manufacturing for suspension processes up to 2,000-liters and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further advantages clients in bringing their critical therapies to market. For more information, please visit andelynbio.com and follow Andelyn Biosciences on LinkedIn.
About ENCell Co., Ltd
ENCell Co., Ltd. is a cell and gene therapy (CGT) CDMO headquartered in Seoul, Republic of Korea, playing a leading role in advancing CGT development and manufacturing across Korea and the broader Asia-Pacific (APAC) region. In addition to its CDMO services, ENCell is actively engaged in the development of novel therapeutics based on stem cell technologies, with capabilities spanning the full value chain from development through manufacturing. Leveraging extensive experience across a wide range of indications and CGT modalities, ENCell provides customized process development and manufacturing services tailored to the needs of global clients. The company operates dedicated facilities for gene therapy production, including independent GMP suites designed for AAV and lentiviral vector-based manufacturing, ensuring high-quality and reliable production capabilities.
SOURCE Andelyn Biosciences
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