New suite operational at Roche’s Carolina API plant

By Gareth Macdonald

- Last updated on GMT

Related tags Influenza Roche

A new $60m (€43m) manufacturing suite is operational at the South Carolina, US plant where Roche makes APIs for some of its leading products, including for its anti-flu drug Tamiflu (oseltamivir).

The Florence plant also produces the active pharmaceutical ingredients (API) in Xeloda (capecitabine), Pegasys (peginterferon alfa-2a) and Xenical (orlistat) as well as several others in clinical development.

A company spokesman told in-PharmaTechnologist that the expansion “fills a need for strategic capacity for current and future products,” ​adding that “Roche will continue to invest in its own facilities as well as outsource where appropriate​.”

He did not say whether the facility will produce components for any drugs made by Roche’s recent $47bn acquisition Genentech, but did confirm that none are made there at present.

Roche is in the process of recruiting 25 new process engineers and industrial chemists which, when complete, will bring the headcount at the 330,000 square foot facility to around 330.

Tamiflu production scaled up

While the Florence expansion project began in 2007 well before cases of H1N1 “swine flu​” began emerging, the additional Tamiflu capacity it provides fits well with Roche’s efforts to ramp-up manufacture.

Earlier this week the Swiss firm told the Wall Street Journal​ it will “increase production to 36m treatments a month by year-end,”​ in response to a surge in demand for Tamiflu.

In the shorter term, Roche has donated 5.65m does of Tamiflu to the World Health Organization (WHO) and has announced plans to make 110m more over the next five months.

David Reddy, head of Roche’s global pandemic preparedness task force, said: “Roche has been rapidly increasing production of Tamiflu at multiple points in the supply chain​,” explaining that “actual production output is dependent upon continued demand from governments for pandemic stockpiles of Tamiflu​.”

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