Bioprocessing Skin Deep

You, too, can manufacture drugs.

ALEX LASH

Imagine a drug factory that never closes, takes up virtually no space, and needs no workers. Medgenics, an Israeli-U.S. biotechnology firm, is building just such a plant. But the Biopump, as its “factory” is called, is no bricks-and-mortar building—it�s a tiny patch of a patient�s own skin, genetically engineered outside the body and then reintroduced to pump therapeutic proteins into the bloodstream. The company claims that a Biopump will obviate the need for frequent injections and will avoid the dangers of gene therapy. The first clinical trial began in October.

The market for therapeutic proteins, which the Biopump would deliver, is already valued at $30 billion annually and could double by the end of the decade, according to the research firm Datamonitor. The industry is entering a critical period: dozens of drugs are in late-stage development and several key patents are due to expire and open the door to generic competition by the end of 2005, so companies are hunting for ways to distinguish their products. Several companies, including Medgenics, are racing to produce alternatives to the needle to make these drugs easier to deliver. (Disclosure: Acumen�s science editor, Barry Sherman, is a consultant for Medgenics and helped design its clinical trial.) The Biopump has roughly the dimensions of a toothpick, about 30 mm by 1 mm. The exact size and shape, as well as the precision of the proprietary tools used to harvest the skin, are crucial for allowing the piece of flesh to become a self-sustaining, histocompatible cell structure outside of the body, what Medgenics founder Andrew Pearlman calls a microörgan. It�s big enough to avoid the time-consuming process of growing a cell line but thin enough that its nutritional requirements are met through passive diffusion in a defined growth medium.