EVERY INNOVATIVE pharmaceutical on the market today got there only after an expensive trip through what people in the drug industry call the pipeline. It's a trip that takes years if not decades to complete.
At the start of the journey is a target: a cell, protein, or molecule that scientists believe is implicated in a disease. In small-molecule drug discovery, chemists typically bombard the target with one molecule after another, looking for a chemical that acts on it in a medically useful way.
After chemists hit on a promising molecule, they turn to developing a process with which they can make it at a reasonable cost. Numerous synthetic routes, catalysts, and reaction conditions are considered. Once they have a process—and the molecule has passed successfully through a battery of efficacy and safety trials—the chemists and their engineering colleagues are ready to manufacture the molecule so it can emerge from the pipeline as an approved drug.
There was a time when drug companies would undertake these steps—discovery, process development, and manufacturing—on their own. These days, however, most firms engage an outside partner to help with at least one of them.
In the pages that follow, C&EN presents three case studies of outsourcing relationships along the drug development pipeline. In the first case, a Belgian drug company enlists the aid of a Midwest contract research firm that has a novel technique for discovering potential drug molecules.
In the second case, one of the best-known U.S. drugmakers partners with a California company that uses gene manipulation to create new biocatalysts. Together, they develop an environmentally friendly reaction step that yields a critical drug intermediate.
And in the third case, a French biotech company turns to a Dutch fine chemicals maker for help with a potentially dangerous manufacturing route. Thanks to a pioneering microreactor-based technique, the Dutch company wins a contract to make a drug that could become a blockbuster arthritis medication.
As these case studies show, all kinds of outsourcing is done along the drug pipeline by pharmaceutical companies big and small. But the three stories have one thing in common: More than being just a helping hand, the outsourcing partners all contribute something unique that the drug companies couldn't have done on their own.