It’s a harsh reality of the drug business: The only way to make money is to keep the pipeline full of new products.
Yet a drug takes something like $800 million and 10 years to get from the lab bench to patients, and at any time in the process, side effects or adverse outcomes can scuttle its approval. So biotech companies are always looking for ways to catch pipeline-clogging troubles early. Their latest guinea pigs aren’t animals or people, but machines.
Hardware that simulates human physiology lets drugmakers experiment in bulk, on the cheap. Most of the new high-speed tools use robot-driven, microscopic arrays – like miniature test tube racks – to try thousands of chemicals at once. In the worst case, a potential medication might be toxic. Because the human organ that copes with toxicity is the liver (it metabolizes compounds into either benign or harmful byproducts), Solidus Biosciences of Troy, New York, sandwiches drug candidates between liver enzymes on one microscope slide and cells from various human organs on another. The enzymes break down the drugs, exposing organ cells to the metabolites and revealing any toxicity.
In another, somewhat broader approach, a San Diego company called Kalypsys uses a robotic arm to fill 1,536 tiny wells with a mixture that includes human cells and up to 1.5 million different chemicals per day. The resulting data show toxicity, purity, and metabolic activity.
“It gives you a glimpse of what’s at the end of the tunnel,” says Kalypsys CEO John McKearn.
By Eilene Zimmerman