Features
Biotech industry squeezed by lack of ‘breweries’
VACAVILLE — In a gleaming drug factory rising out of a California pasture, thousands of genetically engineered Chinese hamster cells multiply into the billions as they snake through 20 miles of pipes, tubes and giant brewers’ vats called “bioreactors.”
Through a series of filters and chemical reactions, the human proteins created in these hamster ovary cells are sucked out, purified and turned into the blockbuster cancer drug Herceptin as well as two other protein-based therapies.
Combined with another factory in South San Francisco, the new plant gives Genentech Inc., the ability to brew in about a month nearly 200,000 liters worth of hamster cells spliced with human genes.
These hardy cells are the industry standard for manufacturing protein-based drugs because of their ability to multiply quickly.
And nobody brews more cells than Genentech, which controls half the world’s bioreactor capacity. Its position is so dominant that Amgen Inc., the world’s largest biotech company, is leaning on No. 2 Genentech for manufacturing help.
“That’s a great position to be in,” said David Ebersman, a Genentech senior vice president in charge of operations.
Demand for the 30 protein-based drugs now on the market far outstrips the industry’s production capacity. And with a good portion of the 99 protein-based drugs now in late-stage human trials expected to hit the market soon, the shortage will get much worse before it gets any better.
By 2005, the industry will need about four times the capacity it has now, predicts analyst David Molowa of J.P. Morgan Chase. He and other analysts aren’t optimistic that future demand will immediately be met.
The expansion plans of a handful of companies, such as Cambridge, Mass.-based Biogen Inc., which is building a 120,000-liter plant in North Carolina, will still leave more demand than capacity, Molowa said.
There simply are not enough of the large, brewery-like fermenters to go around.
Some companies are exploring creative solutions, experimenting with growing the human proteins in tobacco and other plants, and in the milk of goats and cows. But any breakthroughs in these “transgenic” experiments are at least a decade away.
