4) Explore New Modes of Manufacturing
Each successful biotech drug comes with a major headache: figuring out how to make it cheaply. Unlike traditional medicines, which are pure chemical concoctions, biotech drugs are complicated protein-based molecules. They're often grown in live mammalian or yeast cells in networks of costly equipment, such as fermentation tanks. The average biologic plant costs more than $300 million to build -- an expense that few companies have been willing to swallow. In fact, there is such a shortage of manufacturing space that in two years, the demand for biotech drugs could outstrip supply by more than 110,000 liters, according to Strategic Decisions Group.
Several companies are building new factories, including Amgen and Biogen (BGEN ). And they're on the lookout for technologies that would increase output without jeopardizing the quality and safety of the product. Some are even considering radical alternatives to traditional manufacturing, such as growing biotech drugs in eggs, goat's milk, or plants.
The founders of Epicyte Pharmaceutical Inc. in San Diego are placing their bets on corn. Specifically, they're engineering the plants so they produce antibody-based drugs in their seeds. One benefit: Biotechs could quickly adjust crop sizes to meet anticipated demand, and "they could use the sun as their energy source," says CEO Lloyd M. Kunimoto. He estimates that an average company producing 300 kilograms of drug per year in corn would save $65 million in manufacturing costs. Biotech divisions of Johnson & Johnson (JNJ ) and Merck & Co. are working with Epicyte to explore antibody production in plants.
There are risks. ProdiGene Inc. in College Station, Tex., had to pay a $250,000 fine to the Agriculture Dept. last year after leaves and stalks from genetically engineered corn were found in nearby soybean fields. But with new safety guidelines recommended by the FDA last September, fields of drugs may be just a few short harvests away.