By Randall Osborne

SAN FRANCISCO - Genentech Inc.'s $250 million manufacturing plant in Vacaville, Calif., is gearing up to produce the breast-cancer drug Herceptin (trastuzumab) in the second quarter of this year, said Frank Jackson, general manager of the plant.

"It's an impressive facility," said Jackson, with obvious pride. Jackson helped steer planning of the 310,000-square-foot plant from its conception, in 1994.

Tooled for large-scale, mammalian-cell culture manufacturing, the Vacaville addition to Genentech's biotechnology arsenal will provide one-and-a-half to two times the capacity of its South San Francisco facility.

Although Herceptin, approved by the FDA last September, will be the first drug produced at Vacaville, the plant was designed with other products in Genentech's pipeline in mind.

"We're happy to say we still have a need for that," Jackson told BioWorld Today. Among the products is RhuMAB-E25, an anti-IgE drug.

With collaborators Novartis Pharma AG, of Basel, Switzerland, and Tanox Biosystems Inc., of Houston, Genentech is testing RhuMAB-E25 in patients with allergic asthma. A Phase II study showed positive results last year. Phase III study results for that indication, and for hay fever, are expected this year. (See BioWorld Today, Nov. 10, 1998, p. 1.)

IgE, to which RhuMAB-E25 binds, is one of five kinds of immunoglobulin that send antibodies to attack antigens, causing an allergic reaction and thus preventing the release of inflammatory mediators including histamine, prostaglandins and leukotrienes.

"Other [drugs] could require a bigger capacity," Jackson said. Genentech bought 100 acres of land in Vacaville, and has landscaped and done utility work on 30 acres so far.

"On that first 30, we could add a second or even a third manufacturing plant like the one we've just built," he said. Processes at the new facility must be tested, validated and approved by the FDA.

Vacaville was chosen as the site after much deliberation, Jackson said.

"We did consider a different country or different states within the U.S., but California provided incentives at the state, local and city government levels and from the utility companies," he said.

"Producing biologicals is technically complex, so technology transfer and the ease of doing that was an important factor," he added. "All in all, we decided to stay in California, but [the new plant] had to be a separate one from South San Francisco, for mitigation of disaster. It would be silly to build a second plant in the same place, and have the San Andreas Fault wipe out both facilities in an earthquake."

The five-building complex is staffed by about 200 people, and will grow to 300 by the end of the year, Jackson said.

"This is just the need we have for 1999," he said. "We're looking at capacity demands."

Chiron Corp., of Emerville, Calif., has a small facility in Vacaville, and Alza Corp., of Palo Alto, Calif., has larger operations there, he noted. n

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