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Biotech's rich promise is truly fulfilled only when its scientific breakthroughs are transformed into safe, effective therapies, made available in quantities sufficient to treat all those in need. This extremely complex and demanding task is the responsibility of Genentech's Product Operations (PROP) organization, which is composed of process science, quality, facilities/engineering, regulatory and manufacturing services. Each area performs specific tasks on which the other areas depend — so making quality medicines becomes a highly synchronized collaborative effort — right down to the final manufacturing process. The success of PROP is not only critical to the overall success of the company, but is essential to meeting the needs of patients. For this reason, Genentech is continually evaluating, strengthening and expanding its Product Operations organization to meet the highest standards of quality and excellence.
In just 25 years, Genentech has built the quality and capacity of its production systems to include one of the largest, most advanced biologics manufacturing operations in the world. From its South San Francisco campus to new facilities in Vacaville, Calif., and overseas, Genentech has aggressively grown its product operations capabilities — and staffed them with highly skilled, experienced people — to anticipate the demands of an ever-growing pipeline.
2000 was an important year for Genentech Product Operations. At the South San Francisco campus, the company augmented its state-of-the-art capabilities to begin commercial production of two newly approved medications: TNKase and Nutropin Depot. The Vacaville facility received FDA licensure, marking the culmination of a major gearing-up effort.
Following the plant's completion in 1998, the staff conducted trial production runs, produced qualification lots of Herceptin and demonstrated the ability to produce bulk quantities. This cutting-edge facility occupies 310,000 square feet on a 100-acre site, and is the world's largest biotechnology manufacturing plant for the large-scale production of pharmaceutical proteins from mammalian cells. In addition to Herceptin, Vacaville currently manufactures Xolair, a unique anti-IgE monoclonal antibody awaiting FDA approval for the potential treatment of asthma and seasonal allergic rhinitis.
In the year 2000, Genentech also acquired a cell culture manufacturing facility in Porriño, Spain. Built in 1976, the 40,000-square-foot plant formerly manufactured interferon. The facility now operates as a wholly owned subsidiary company, Genentech España S.L., and will supplement Genentech's existing bulk cell culture production capacity.
Genentech is ready to continue evolving its product operations at all three sites to meet the demands of the next quarter century. The Vacaville facility has room to expand capacity another twofold, and current plans call for increasing output there by some 50 percent. The company is also expanding its expert workforce — the solid manufacturing experience of its new employees in Spain goes back nearly three decades, and in South San Francisco and Vacaville, Genentech continues to hire and retain the best and brightest talent in biotech.