Amgen to build biologics drug substance manufacturing facility in North Carolina

By Rachel Arthur

- Last updated on GMT


Related tags Amgen Manufacturing Biologics Drug substances

Amgen will build a new multi-product drug substance manufacturing facility in Holly Springs, North Carolina.

Combined with its new packaging plant in Columbus, Ohio (announced in June), Amgen is putting $1bn into additional manufacturing capacity to support predicted demand for its medicines in the coming years. 

Mixing traditional & next-gen technologies for optimum effect

The new $550m plant in Holly Springs, North Carolina, will be located near the Raleigh-Durham area’s Research Triangle Park: anchored by the major research universities of North Carolina State University, Duke University and University of North Carolina at Chapel Hill.

The new plant will support both traditional stainless steel-fed batch manufacturing and next-generation single-use technologies (the exact balance is still being defined as the company completes its design). This combination of capabilities is an approach that Amgen calls ‘FleXBatch’ manufacturing, which it says will make the facility more flexible and efficient, as well as requiring a smaller physical footprint than a traditional plant.

"FleXBatch is a new manufacturing concept that is a hybrid facility combining both traditional stainless steel-fed batch manufacturing and next-generation single-use technologies, allowing flexibility for multiple pipeline products in one plant. Amgen has extensive experience with traditional stainless steel fed batch and single use technologies and will leverage this experience as we bring these technologies together."

Construction is expected to begin in December this year, with the facility set to be completed in late 2024. The plant will bring up to 355 full-time jobs to the region by 2029, including engineers, technicians, quality, management and administrative roles.

California-headquartered Amgen focuses on six therapeutic areas: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation.

A substantial portion of Amgen’s total supply of medicines is produced in the US: including sites in California, Rhode Island and Massachusetts. Its largest manufacturing facility globally is located in Puerto Rico, which employs 2,400 staff across 22 buildings. The company also has sites in Ireland and the Netherlands; while it also opened a facility in Singapore in 2014.

“Amgen has a long history in biologics manufacturing and continues to innovate and develop new technologies to better serve patients. At this new facility, we plan to include some of our most advanced technologies,”​ said Arleen Paulino, Amgen senior vice president, manufacturing. “We chose North Carolina for this new plant because of the robust biologics ecosystem, and we are excited to partner with the Wake County business community to further expand biotechnology regionally.”

Final product assembly and packaging plant: Columbus, Ohio

Announced in June, the new greenfield facility will assemble and package vials and syringes to support the growing demand for Amgen’s medicines. Plant construction is slated to begin in the fall this year, with $365m of investment planned for the site. At full capacity, Amgen plans to hire 400 full-time staff, including technicians and engineers, along with quality assurance, quality control, administrative and management positions.

The site is expected to be operational by 2024.

Multi-product drug substance manufacturing plant: Holly Springs, North Carolina

Construction of the $550m plant will begin in December, with an estimated completion date of late 2024. It will bring up to 355 full-time jobs to the region by 2029, including engineers, technicians, quality, management and administrative roles.

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