Manufacturing a biotech drug is a lot like making beer: You brew it in a temperature-controlled vat. But keeping the vat clean and productive can be pricey. So pharmaceutical makers are instead modifying the DNA of plants and animals, with the hopes of turning them into efficient biological factories. In theory, the process is simple: Insert a gene that produces a desired protein into a compatible host, then purify the compound and sell it as a drug. In practice, this isn't as easy as it sounds. Drugmakers have to ensure the inserted genes don't jump the fence into the wild or the food supply, among other things. But they're already putting genetically tweaked flora and fauna to work. Here are eight potential products coming soon from bioreactors that bloom, moo, and bleat.
Illustration by Feric Drugs being made inside plants and animals
Drug: Atryn (Antithrombin)
Source: Goat Milk
Function: It's a blood protein that regulates clotting and makes surgery safer.
Company: GTC Biotherapeutics, Framingham, Massachusetts
Status: Approved in Europe for some uses.
Drug: Rhucin (C1 Esterase Inhibitor)
Source: Rabbit Milk
Function: Without it, people's skin, airways, and bowels swell with fluid. The condition, called hereditary angioedema, causes excruciating pain and sometimes death.
Company: Pharming Group NV
Status: Rhucin is under review in Europe.
Product: Lactoferrin
Source: Cow Milk
Function: This protein fights infection by sopping up the iron that microbes require to grow.
Company: Pharming Group NV, Leiden, the Netherlands
Status: A filing for GRAS (generally recognized as safe)
Status: is under review by the FDA.
Drug: Locteron
Source: Duckweed
Function: Its main ingredient, interferon alpha, is a protein the body uses to fight viruses.
Company: Biolex Thera-peutics, Pittsboro, North Carolina
Status: Human trials to test efficacy for hepatitis C are under way in Europe.
Product: Gastric Lipase
Source: Corn
Function: This enzyme helps people with cystic fibrosis absorb fat.
Company: Meristem Therapeutics, Clermont-Ferrand, France
Status: Meristem is completing Phase II trials. (Anticipates entering Phase III by early 2008.)
Product: Lactoferrin and Lysozyme
Source: Rice
Function: These infection fighters are put into rehydrating solutions to prevent the recurrence of diarrhea.
Company: Ventria Bioscience, Sacramento, California
Status: Human trials conducted in Peru were promising but controversial because they included children. US trials are under way.
Product: Insulin
Source: Safflower seeds
Function: This protein — ordinarily made in the pancreas — helps control how the liver processes sugar. It's used to treat diabetes
Company: SemBioSys, Alberta, Canada
Status: Phase II human trials are expected to start in 2008.
Drug: CaroRx
Source: Tobacco
Function: This antibody sticks to the bacteria that cause tooth decay, keeping them offyour pearly whites.
Company: Planet Biotechnology, Hayward, California
Status: In Europe, formula tested safe for humans, but efficacy has yet to be determined.
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