Genentech heads toward completion of Oceanside plant

By: BRADLEY J. FIKES - Staff Writer | Tuesday, December 13, 2005 8:54 PM PST ∞

OCEANSIDE ---- Workers scrambled Monday morning to prepare for the harvest of one of the most valuable crops ever grown in North County: a broth containing cultured cells.

That broth contains one of the biggest-selling drugs for biotech giant Genentech Inc.: a compound called Avastin that treats metastatic cancer of the colon or rectum.

A few weeks ago, Genentech employees in the company's giant new manufacturing plant in Oceanside took a clump of cells from a liquid nitrogen-cooled freezer and began growing them in a nutrient bath in fermentation tanks. The cells, originally taken from the ovaries of Chinese hamsters, have been genetically modified to secrete Avastin. On Tuesday, the company began to separate Avastin from the broth, a process the company refers to as "harvesting."

"Each batch can treat hundreds or thousands of patients, and is worth millions of dollars," said David Broad, Genentech's vice president and general manager of Oceanside product operations. This particular batch is a test run, the second made in the plant's "fermentation suite." (Broad said the first test, performed earlier this fall, was a success. Results from the second test are not yet available.)

Next year, the South San Francisco-based company will be attempting to convince the U.S. Food and Drug Administration that it can produce Avastin in the Oceanside plant according to the exacting rules known as Good Manufacturing Processes. About 430 people now work at the plant; an additional 100 people will be hired at the plant in 2006, Broad said.

If all goes well, Genentech will begin selling Oceanside-made Avastin in 2007, said Broad, who led a North County Times reporter and photographer on a tour of the facility Monday. Such a tour won't be as easy several months from now, when the company has completed its remodeling of the 500,000-square-foot plant, which it bought in June from Biogen Idec for $408 million.

The precautions against contamination make it extremely difficult to admit outsiders to production areas that must be kept sterile and immaculate. Everything in the manufacturing process is monitored: The water is purified to the level where it can be safely injected into people; this water is piped around the building for easy access. Incoming raw materials are stacked in a warehouse area that Broad likened to Home Depot; all the materials are tested and labeled before use. The fermentation tanks and everything else that touches the cell broth are sterilized.

Even the air is scrubbed by filters. "Clean rooms" and other sensitive areas connect to the outside via a chamber, where visitors don protective gear. To prevent dirty air from flowing inside, the interior and exterior chamber doors cannot be open at the same time. In addition, the clean rooms maintain slightly greater air pressure than normal, causing an audible "whoosh" when the interior doors open.

It's jarring to pass from such a minutely controlled environment to areas still under construction. In another room, welders are installing equipment in an environment evidently not yet clean-room ready (or perhaps not intended for clean-room status), with rock music blasting from a portable player.

As with traditional beer and wine fermentation, biotech fermentation consists of cells cultured in a nutrient solution. The cells are only a means to an end: the product they secrete. The stainless steel fermentation tanks even resemble those you can see at the local microbrewery, although with far more controls and dials.

Once the growing process is complete, the Avastin-containing broth goes through a number of steps to produce the purified product. Technicians mix an Avastin-adhering gel into the broth, then wash the gel to remove the Avastin.

The resulting liquid is spun in a centrifuge at 5,000 to 6,000 rpm to remove cells and large particles. The broth is then filtered to remove more particles; the filters have pores of 0.2 microns, or millionths of a meter. The pure Avastin will then be sent out of the Oceanside plant in bulk, to be placed in vials at another location, Broad said.

For more information about Genentech's Oceanside operations, go to www.oceansidebiotech.com.

Contact staff writer Bradley J. Fikes at (760) 739-6641 or bfikes@nctimes.com.

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