gilead_hq_at_stockley_park_london

Gilead to shift plant and expand US manufacturing

pharmafile | September 30, 2014 | News story | Manufacturing and Production AmBisome, Cayston, Gilead, San Dimas, Viread, california, manufacturing 

Gilead Sciences will move its US manufacturing plant about 15 minutes down the road to a 23-acre site in the southern California city of La Verne that will employ 500 people.

Gilead’s facility of up to 400,000 square feet could replace a drug manufacturing plant in nearby San Dimas, according to local news reports in the Inland Valley Daily Bulletin.

Officials from the firm, which makes the major blockbuster hep C pill Sovaldi, have not yet formally announced the plans or given any more public information about the company’s potential move.

Gilead which is reshaping its massive Foster City headquarters campus, this year added a new automated production line in San Dimas for the inhaled cystic fibrosis treatment Cayston.

Gilead has produced Cayston, the HIV drug Viread, the antifungal drug AmBisome and the injectable wet age-related macular degeneration drug Macugen all at the San Dimas plant.

The facility was the focus of an FDA warning letter in 2010 that raised concerns about the manufacturing environment for AmBisome, quality procedures and controls for Viread and “a generalised concern over the effectiveness of the San Dimas quality unit in carrying out its responsibilities”.

Delays with the expansion of manufacturing Cayston at San Dimas and in qualifying two other sites, meant that for seven months in 2012 Gilead had to stop patients with new prescriptions from using the drug.

Gilead has another Southern California manufacturing site in Oceanside.

Ben Adams 

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