Genentech's Vacaville Facility Granted FDA Licensure

Genentech Inc. (South San Francisco, CA) announced on April 25 that its new manufacturing facility in Vacaville, CA has passed regulatory inspection by the U.S. Food and Drug Administration (FDA). The agency found all validation and production lot data to be acceptable for producing Herceptin (Trastuzumab), Genentech's leading breast cancer drug.

Genentech's newly-licensed Vacaville manufacturing facility is the largest protein factory on earth.

Vacaville's licensure enhances Genentech's ability to meet growing demand for Herceptin, which up to now had been produced at the firm's South San Francisco site. With licensure under its belt, Vacaville officially becomes the world's largest biotechnology manufacturing plant for large-scale therapeutic protein production. Plant construction began in 1995 and it became fully operational in 1999, at which point Vacaville began its licensure process and started building Herceptin inventory.

Genentech's main business is therapeutic monoclonal antibodies which seek out and attack diseased cells.

Licensure is the last step required for the manufacture and distribution of a marketed drug. Before FDA allows a product to be produced at and distributed from a new facility, the site must pass through several phases: startup, validation, trial runs, qualification lots, building of inventory, FDA inspection, and finally licensure.

Genentech acknowledged the role played by the city of Vacaville, which according to company spokesman Geoffrey Teeter played no small role in helping Genentech meet timelines and create a "world-class manufacturing facility."

Genentech's corporate headquarters in South San Francisco, CA.

Herceptin is the first monoclonal antibody for treating certain metastatic breast cancers in patients who over-express the HER2 protein. Cancer in women who over-express HER2 tends to be more aggressive. FDA approved Herceptin in 1998.

Vacaville boasts more than 400 full-time employees, working in seven buildings totaling 310,000 square feet on the 100-acre site. Genentech is already planning to add capacity and employees to meet the manufacturing needs of Genentech's monoclonal antibody pipeline drugs, in particular E25 (for treating allergic asthma and seasonal allergic rhinitis) and anti-CD11a (moderate-to-severe psoriasis). Genentech has 20 protein-based drugs either in clinical trials or awaiting approval, plus 13 drugs on the market.

For more information: Geoffrey Teeter, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080-4990. Tel: 650-225-8171. Fax: 650-225-6000.

By Angelo DePalma