All told, Genentech has earmarked $1.7 billion for capacity expansions in 2005 as part of a refocusing of its manufacturing activities that will also see the termination of its contract to make Amgen's rheumatoid arthritis drug Enbrel (etanercept) and another unnamed biologic drug, at a cost to Genentech of $41m.
The announcement is likely to dash any hopes held by contract manufacturers to win contracts to make what could be a swathe of new and growing products for Genentech, which has reported a series of positive late-stage clinical trial results in recent months, including for its new cancer drug Avastin (bevacizumab).
Pat Yang, senior vice president, product operations, at Genentech told a conference call that the firm has drawn up an "aggressive production plan that will utilize nearly 100 per cent of our capacity in the near-term."
The Oceanside facility would add 90,000 litres in bioreactor capacity to Genentech, as part of a strategy to 'build capacity ahead of demand'. The facility is due to start production in 2006 and should be licensed by the US Food and Drug Administration (FDA) in 2007.
But while significant, this plant is only part of the story. Genentech runs an existing facility in South San Francisco that currently has six licensed 12,000 litre reactors, plus two 12,000-litre reactors currently being used to make Enbrel. These will be switched to make Avastin, said Yang.
In addition, Genentech's Vacaville facility in California now consists of two plants - CCP1 which has twelve 12,000 litre reactors - and CCP2 which is currently being built but when complete will add a further eight 25,000 litre units. This facility, which has a price tag of around $600m plus start-up and validation costs, is scheduled to start operations in 2009.
Finally, Genentech's manufacturing facility in Porrino, Spain, currently has four 10,000-litre reactors of which two are being used to make Avastin clinical trial materials. The company hopes to get approval to use the facility for commercial production of Avastin this week, and will add two additional reactors to make the drug, which should be approved in 2006.
Genentech also provided an update on its manufacturing partnerships, noting specifically that Lonza, which has an agreement to manufacture the bulk drug substance for Genentech's cancer treatment Rituxan (rituximab), is expected to produce around 50 per cent of the biotech's requirements for this drug over the next few years. Lonza's Portsmouth, New Hampshire facility is currently being reviewed by the FDA for this purpose and should secure approval in late 2005.
Meanwhile, Novartis will make all of the bulk substance for asthma treatment Xolair (omalizumab), and the two companies plan to file for manufacturing approval in the third quarter of 2005 and anticipate licensure in early 2006. Genentech also expects licensure by the end of 2006 to manufacture breast cancer drug Herceptin (trastuzumab) bulk active at Wyeth's Andover, Massachusetts facility.
Overall, by early 2007 Genentech expects to have 370,000 litres of licensed manufacturing capacity, in addition to licensed capacity at several contract sites. Licensed internal capacity should increase to 570,000 litres by the first half of 2009.