Roche Bulk Active Ingredient Manufacturing Facility, Florence, SC, USA

Roche Carolina is the highly successful US subsidiary of pharmaceutical giant Hoffman La Roche. Roche has had a process development and bulk active ingredient manufacturing facility on a 1,400 acre (567 hectare) site in Florence, South Carolina since 1995 when the facility started production with only 20 employees relocated from the Roche US headquarters in Nutley, New Jersey.

The plant manufacturing capacity was expanded again in 1998 and in 2007 further expansion is going ahead to the tune of over $60m (€45m).

This project will involve the installation of a multipurpose production unit in an existing manufacturing building. The plans call for construction to begin in summer 2007 and be completed by the end of 2008, with operations to begin in early 2009.

The expansion will create 25–30 process operator positions at the plant which currently employs around 70 chemists and technicians. Roche Carolina has been able to obtain funding from the City of Florence, as well as the state, in terms of tax credits for investments and technical training programmes.

BOOSTING TAMIFLU PRODUCTION

Tamiflu could be one of the mainstay drugs in the treatment of H5N1 bird flu if there was a pandemic in the human population. Roche has received major orders from governments all over the world for quantities of the drug to stock pile for just this instance and consequently Roche has been trying to increase its manufacturing capacity of Tamiflu.

While the company has reached its target capacity of 400 million doses a year they are trying to increase capacity again and part of this capacity expansion is at the Roche Carolinas plant in Florence. A trigger for a major increase in production would be if the World Health Organization finds that human-to-human transmission of bird flu has occurred, which could signal the start of a pandemic.

Roche currently has over 215 million treatments on order. Tamiflu is still proving an enormous commercial success for Roche because of fears that a global flu pandemic may be around the corner. Sales in 2006 increased 68% to €1.6bn, although the rate of growth slowed to 47% in the first quarter of 2007.

CONSTRUCTION AND CONTRACTORS

The company awarded the contract for general construction to McCrory Construction LLC. PEARSON Management is to provide construction management services. The expansion project will increase the number of production units at the facility from three to four, operating alongside Roche Carolina's development laboratories, and provide a significant increase in manufacturing capacity. The unit can already handle multi-step organic synthesis from small demonstration lots to metric ton commercial-scale production.

When the first plant was constructed on the site in 1995, the roofing was carried out by Fort Roofing & Sheet Metal Works Inc and the building had architectural glass features incorporated in its design by Frank Close architectural stained glass. F&ME Consultants were appointed to advise on geotechnical and environmental issues. Gregory Electric undertook the electrical fitting out of the plant.

PRODUCTION

The Roche Carolina facility manufactures the active ingredients for the manufacture of Xeloda (capecitabine) [cancer treatment], Pegasys (peginterferon alfa-2a) [hepatitis treatment], Xenical (orlistat) [weight-loss drug] and Tamiflu (oseltamivir) [flu medicine]. Roche also makes these active ingredients at four other sites around the world, but the Florence facility was selected because of a robust infrastructure already in place.

According to the company when the first plant was constructed, the building, the utilities and the heating and cooling transfer system were purposely oversized for the job. This makes expansion at Florence much easier. Roche has only developed about 200 acres (81 hectares) of the 1,400 acre Florence campus and so there is ample room for expansion.

In addition, the first plant at Florence has highly automated manufacturing operations that were designed with a high level of flexibility in mind. This allows the company to change over manufacture to new chemicals with no major capital investments and also to integrate new expansions into the existing operation.

Roche Carolina focuses on process development for the Swiss parent, as well as the supply of clinical trial materials. It has contributed to the development of manufacturing protocols for a number of Roche's leading brands.

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