Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin), a global specialty pharmaceutical company based in Japan, this week announced that its board of directors approved plans to invest up to $530 million to build a new, state-of-the-art manufacturing facility in Sanford, N.C. 

The 171,700-square-foot, two-reactor facility will accelerate the company's development and production of biologic therapies for patients with rare and serious diseases while contributing to the Sanford area's economic growth and development, according to a company press release.

"The extraordinary complexity of the medicines we manufacture requires specialized skills and resources that are in plentiful supply in Sanford and the Research Triangle region," said Paul Testa, executive vice president and regional head of North America/EMEA Manufacturing for Kyowa Kirin North America. "We're excited to collaborate with area colleges, universities, businesses, and civic leaders to ensure that our plans align with Sanford's vision for growth, anchored in a rejuvenated manufacturing economy that offers diverse job opportunities and returns value to the community."

The company said that a key driver of the new manufacturing facility is the growing global imperative to treat diseases that individually are rare, but which collectively affect an estimated 263 to 446 million people worldwide. Kyowa Kirin believes it is uniquely positioned to fulfill the unmet needs of patients with rare and underserved diseases by continuing to build on its more than 70-year history of discovering and developing novel medicines that can offer life-changing value to patients.  

The new facility will manufacture biologic therapies, including next-generation antibodies, for the company's planned clinical trials and future commercial use while creating more resilient and efficient supply lines that more readily withstand shifting global forces. The 75-acre campus at Helix Innovation Park at The Brickyard will allow for future expansion, should the company's portfolio necessitate greater capacity as its pipeline programs advance. 

Construction of the facility is expected to begin in the second half of 2024 and become fully operational in 2027. Kyowa Kirin's investment of up to $530 million will be supported by performance-based state and local incentives to Kyowa Kirin, announced in February, of $10 million over 12 years, which are estimated to grow the state's economy by $1.05 billion over the course of the grant, according to the North Carolina Department of Commerce. The plant will create more than 100 new local jobs at an average salary of $91,496. 

"Our North American presence continues to grow through strategic investments that are adding new capabilities, new therapeutic expertise, and new talent to our global organization, all in service of meeting patients' needs," said Steve Schaefer, Kyowa Kirin North American president. "Among the many qualities that drew us to North Carolina are our shared values, such as harmony and teamwork known as Wa, which is deeply engrained in our culture at Kyowa Kirin, evident in our longstanding corporate partnerships, and fundamental to high-quality pharmaceutical manufacturing." 

The Sanford facility will round out and enhance Kyowa Kirin's global manufacturing network, which includes sites in Takasaki City, Gunma Prefecture, and Ube City, Yamaguchi Prefecture in Japan. By building its new site amid North Carolina's robust life sciences hub, Kyowa Kirin will benefit from a thriving network of biomanufacturing resources as well as a rich pool of talent within the greater Research Triangle Park, home to renowned universities and community colleges that provide specialized curricula and training. The new facility will leverage the expertise of these institutions and build upon the manufacturing methods and technologies recently added in Takasaki to further enhance manufacturing productivity and efficiency. 

"I am very excited that Kyowa Kirin is constructing a new manufacturing plant for biologics drug substances in the United States," said Toshiyuki Kurata, Chief Supply Chain Officer and global manufacturing head at Kyowa Kirin. "The new facility will be scalable with our Takasaki Plant in Japan to help ease technology transfer between the two plants and add production capacity. We believe this will help accelerate drug development and production."