- Amgen Inc. will build its planned $160 million biologics manufacturing facility in Rhode Island, announcing on April 10 it would site the plant at its existing 75-acre campus in West Greenwich.
- The new facility will add roughly 150 skilled manufacturing positions — about half the number of skilled jobs Amgen had previously indicated would be associated with its operation. Another 200 construction and validation jobs will be created as part of the buildout.
- Amgen claims the plant will be the first of its kind on U.S. soil, modeled after a biomanufacturing facility the company constructed in Singapore four years ago.
Amgen says construction of the modular facility will take half the time it normally would to build a traditional plant, and at half the cost.
Original estimates by the drugmaker pegged the total investment needed to construct the plant at $300 million. The site is now forecast to cost about $160 million, according to a release from the Rhode Island Governor's Office. The reduction is reportedly due to Amgen's decision to co-locate the new plant on its existing campus.
Amgen's Rhode Island site is currently home to what the company characterizes as one of the world's largest mammalian protein manufacturing facilities. Commercial and clinical bulk drug substances are manufactured at the location.
With the recent changes in U.S. tax law, however, Amgen plans to dedicate a greater portion of its annual capital expenditures to the U.S. This new investment is part of that push. (Amgen forecasts it will pay an effective tax rate of between 14% and 15% this year — down from the 18% tax rate it reported in 2017.)
Advancements such as process intensification upstream have allowed drugmakers to shrink bioprocessing operations without compromising product quality or output, allowing for more opportunities to build flexible facilities.
These more modern plants, which generally use single-use systems (SUS) and modular units throughout, are becoming increasingly attractive due to their quicker build times and lower cost.
Amgen's plant in Singapore, which became operational in 2014, is aimed at expanding the company's monoclonal antibody manufacturing capabilities for both clinical and commercial products.
Shawn Smith, president and CEO of ZeptoMetrix, said in an email that while vendors of single-use consumables for the RI site will likely be the same as those for the Singapore location, Amgen could use the new build as an opportunity to request competitive bids. "Since a new facility would need to be thoroughly validated anyway, it's possible Amgen could make changes," Smith said.
Characterizing a facility as "fully SUS" is a bit of a misnomer, though, said Eric Langer of BioPlan Associates, as many downstream bioprocessing operations haven't all made the switch to single-use components. And while some contract manufacturing organizations could be considered mostly SUS, it's hard to say that any facilities are 100% single use.
Swiss drugmaker Novartis AG also operates a "next-generation" facility in Singapore. And Chinese CMO WuXi Biologics recently poured $150 million into a single-use facility, which become fully operational at the tail end of 2017. It claims this location is the "world's largest" biomanufacturing facility to use solely single-use technologies.
But locating plants overseas isn't without challenges.
"I think companies are finding Singapore a bit more 'distant' than anticipated; as modern technologies 'shrink' the world in terms of communications/connectivity, the day-to-day challenges of operating within a technical environment still require a solid hands-on presence at the local operation," Smith said.