Tuesday, Apr 25, 2000
Vacaville, Calif. -- April 25, 2000 --Genentech, Inc. (NYSE: DNA) announced today that its new state-of-the-art manufacturing facility in Vacaville has passed regulatory inspection by the U.S. Food and Drug Administration (FDA) and all validation and production lot data have been found to be acceptable for the production of Herceptin® (Trastuzumab), the company's breast cancer drug.
"We are extremely pleased with this latest milestone for the Vacaville facility," said James Panek, senior vice president of Product Operations at Genentech. "The licensure of Vacaville enhances our capacity to meet the growing demand for access to this medicine by breast cancer patients."
Genentech's Vacaville facility is the world's largest biotechnology manufacturing plant for the large-scale production of pharmaceutical proteins. Genentech began construction of the facility in 1995 and it became fully operational in 1999. Since then, the facility has been building product inventory of Herceptin and undergoing the FDA licensure process.
Licensure is the last step required for the manufacture and distribution of a marketed medicine. Before a drug can be produced and distributed at a new manufacturing facility, the site must pass through several different phases which include start up, validation, trial runs, qualification lots, the building of inventory, FDA inspection and finally FDA licensure.
"This milestone not only reaffirms the sound business decision to establish the facility in Vacaville, it also reflects several years of hard work, excellent science and engineering and focus. The dedication of our employees made the vision of creating a world-class manufacturing facility a reality," said Frank Jackson, general manager of Genentech Vacaville.
Herceptin, the first product manufactured at the facility, is the first monoclonal antibody for use in the treatment of certain metastatic breast cancer patients who overexpress the HER2 protein. The product was approved by the FDA in 1998 and until now has been produced primarily at the company's South San Francisco headquarters.
Genentech's Vacaville facility currently has over 400 full-time employees, working in seven buildings that total 310,000 square feet on the 100-acre site. Future expansion and additional employees are anticipated in order to meet the manufacturing needs dependent on the success of products currently in the company's robust pipeline. In fact, the company is currently expanding the manufacturing output and capability at the Vacaville facility as part of the original development plan.
Genentech, Inc., is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Thirteen of the approved products of biotechnology stem from Genentech science. Genentech markets seven products directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.
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