Pharmaceutical Business review

Amgen to construct new drug substance manufacturing plant in North Carolina

Amgen headquarters in Thousand Oaks, California, the US. Credit: Amgen Inc..

Amgen has announced plans to construct a new multi-product drug substance manufacturing facility in Holly Springs, North Carolina, the US.

The company is committed to invest approximately $550m. The new plant will be constructed near the Raleigh-Durham area’s Research Triangle Park.

Amgen Operations executive vice-president Esteban Santos said: “Amgen is investing in a technologically-advanced drug substance plant in North Carolina to support the increasing demand for our medicines.

“Together with the previously announced advanced packaging plant in Ohio, we have committed to investing nearly $1bn in new manufacturing capacity in the US.”

The new facility will support traditional stainless-steel manufacturing and next-generation single-use technologies, giving flexibility to produce multiple pipeline of products in one plant.

This approach, dubbed as ‘FleXBatch manufacturing’, will make the new plant more efficient and flexible, requiring a smaller physical footprint compared to a traditional plant.

Amgen Manufacturing senior vice-president Arleen Paulino said: “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.

“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.”

Construction work on the new drug substance manufacturing facility is anticipated to commence in December this year and slated for completion in late 2024.

The plant is expected to create up to 355 full-time jobs in the region by 2029 that include quality, technicians, engineers, management as well as administrative roles.