Roche has opened a Biotechnology Production Centre at its home base in Basel, Switzerland.
The multipurpose facility for the commercial production of therapeutic antibodies and other products derived from cell cultures will initially manufacture bevacizumab, the active ingredient in Roche's fast-growing anticancer drug Avastin, for the European market.
The Swiss group originally announced plans to invest around CHF800m (€485m) in two new European manufacturing facilities for biopharmaceuticals in June 2004. The second plant, which is due to be inaugurated this July alongside an existing facility at Roche's Penzberg site in Germany, will initially produce the active ingredient for another key oncology product, Herceptin (trastuzumab), in Europe.
The two monoclonal antibodies were both co-developed with Roche's US subsidiary Genentech, which has stepped up its own manufacturing capacity substantially in the last couple of years following its $408m acquisition of Biogen-Idec's Oceanside facility in California. Avastin is currently manufactured by Genentech while the US company and Roche share production of Herceptin.
Roche has spent around CHF400m over three years on the Biotechnology Production Centre (also known internally as the Monoclonal Antibody Facility), which occupies the site of a former chemical production plant in Basel. Construction work was completed in just two years. The new building is part of a development scheme that includes consolidating all production facilities in the Basel site's northern sector.
Roche is now preparing the facility for validation and certification by the regulatory authorities. Commercial production of Avastin at Basel is slated to begin in 2009; until then the drug will continue to be sourced from Genentech's manufacturing facilities.
The Biotechnology Production Centre has 6 x 12.5 cubic metres of fermentation capacity and two downstream processing lines (i.e., for the recovery and processing steps that yield the final product). The facility's multipurpose design enables two products to be manufactured at once.
"It is a biotechnology site, not an Avastin plant," Roche commented, although it would not be drawn on its plans for manufacturing pipeline biopharmaceuticals at the facility.
While the primary focus with Avastin will be on supplying European markets, the Biotechnology Production Centre could be used to service other countries "in an emergency", the group noted.
With two basement levels and eight stories, the building has opened up space for 170 new jobs at Roche, including chemical, laboratory and biotechnology production technicians.
Roche already has the largest biotechnology production capacity of any company worldwide, the group points out. In addition to Basel and Penzburg, it has biopharmaceutical manufacturing facilities in South San Francisco (US, Genentech), Vacaville (US, Genentech), Oceanside (US, Genentech), Utsunomiya (Japan, Chugai) and Ukima (Japan, Chugai).
The investments in, and rapid development of, the Basel and Penzberg sites are evidence of Roche's commitment to biotechnology and its confidence in Avastin and Herceptin as growth drivers in the group's core oncology portfolio. Last year Avastin ran up sales of CHF2.96bn, up by 76 per cent year on year, while Herceptin sales were 81% higher at CHF3.93bn.
In the first quarter of 2007, which saw additional approvals of Avastin for the treatment of metastatic breast cancer in Europe and metastatic colorectal cancer in Japan, the drug's sales jumped 41 per cent to 923m Swiss francs.
Avastin has also just been launched in the UK for the first-line treatment of metastatic breast cancer in combination with paclitaxel chemotherapy. Roche says it will be addressing the issue of Avastin's affordability in this indication - at an estimated cost of around £42,000 (€61,630) per patient per year - following the drug's rejection by the National Institute for Health and Clinical Excellence (NICE) as a colorectal cancer treatment on cost-effectiveness grounds last January.
The new biotech facilities in Basel and Penzberg reflect a strategy of keeping manufacturing in-house in the face of rapid product growth, Roche told In-Pharmatechnologist.
"We have always said production is a core element," it commented, adding that the aim was to have capability for all the important stages of a drug's lifecycle, from R&D through to sales and marketing.