Genentech working to license second Vacaville cell-culture plant

East Bay Business Times - December 24, 2007
http://eastbay.bizjournals.com/eastbay/stories/2007/12/24/story7.html


Business News - Local News
Friday, December 21, 2007

Genentech working to license second Vacaville cell-culture plant
East Bay Business Times - by Jessica Saunders
Courtesy file photo by Andrew McKinney

Genentech’s Vacaville cell-culture plant underwent a $600 million expansion and is the world’s largest facility of its kind.
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Genentech is preparing to seek federal licensing for its second cell-culture plant in Vacaville now that construction is completed.

The biotech giant is testing and validating the 380,000-square-foot Cell Culture Plant 2 (CCP2), which paired with the existing CCP1 will form the world's largest cell-culture biotechnology manufacturing plant, according to company research. The validation process verifies systems were designed, built and will operate per specification.

After the 12-month testing and validation process, Genentech will begin producing qualification batches of drugs and apply to the U.S. Food and Drug Administration for an operating license. The FDA process, which includes an inspection, takes about 15 months, a company spokeswoman said.

The company said it expects to receive the license in the third quarter of 2009.

The $600 million expansion of the original 427,000-square-foot plant doubles Genentech's production capacity to 344,000 liters. The plant will create bulk liquid drugs such as Herceptin, Avastin and Rituxan, as well as future drugs.

The general contractor for the expansion, DPR Construction Inc. of Redwood City, reached substantial completion and a temporary certificate of occupancy on June 14, two weeks ahead of the contractual completion date. Substantial completion means the building could be used for its intended purpose, said George Pfeffer, DPR project director and Bay Area regional manager.

In addition to building CCP2, DPR expanded the existing warehouse and doubled the size of the central utility plant. The project required 1,200 craftspeople to work more than 3 million hours over 16 months, while not interfering with production at CCP1.

The work site was extremely congested with more than 1,000 workers confined in 400,070 square feet, making safety a paramount concern, Pfeffer said. Training, daily communication and zero-tolerance policies kept the injury rate at the site to 1.7 per 200,000 hours worked, compared to the industry standard 6.2, he said.

"We drove safety into daily habits of people, in that it was not someone else's job to watch (for it)," said Pfeffer.

Adding to the complicated logistics, DPR agreed that Genentech could take control of finished portions of the plant while 70 percent of construction work was incomplete. Normally, the overlap is 10 percent to 20 percent, Pfeffer said, but it was necessary to compress the construction timeline. DPR began turning over systems to Genentech in September 2006.

"A lot of people in the industry thought we were crazy for taking this on - it was too risky. They thought it couldn't be done in the time frame," he said.

DPR has worked with Genentech for 10 years, including five to six projects in Vacaville and about 20 in South San Francisco, where Genentech is based.

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