Pharma Outsourcing

It’s the rare pharmaceutical company that doesn’t rely on outsourcing partners in the effort to bring new drugs to market. Big drug companies are outsourcing more as a means of managing costs, and small or start-up firms outsource as a matter of necessity.

At a minimum, drug companies need their contractors to do what is requested of them quickly, reliably, and at an acceptable cost. But the best contractors do more. They bring the intellectual prowess of their scientists to bear on the contract. They make improvements the customer didn’t ask for and solve problems the customer didn’t know it had.

On the pages that follow, C&EN presents case studies of three pharmaceutical outsourcing partnerships. In all three cases, the contractor brought scientific skills and problem-solving ability that likely made the difference between success and failure—and definitely made the case for not pinching pennies when outsourcing.

For a contract research organization, problem-solving occurs during drug discovery. In one case study, Anacor Pharmaceuticals hired Naeja Pharmaceutical for help on its novel boron-based drugs. Naeja chemists were instrumental in discovering a unique family of boron-containing compounds, several of which are now succeeding in clinical trials.

For contract manufacturing organizations, the breakthroughs come after the molecule is discovered. In another case study, Provepharm handed Novasep methylene blue, a well-known compound with purity problems that kept it from being a good drug. Starting with a Provepharm process, Novasep scaled up production with remarkable speed while managing to keep impurities low. It helped develop and validate new analytical methods. And then it invested in more scale-up capability to make sure it could support Provepharm’s commercial launch.

In a third case, process chemistry specialist Solvias completely revamped the synthetic route to Vitae Pharmaceuticals’ kidney disease treatment by applying its expertise in asymmetric hydrogenation to cut out process steps and avoid wasteful resolutions. Vitae was impressed enough with the results that it hired Solvias to manufacture the molecule itself.

The chemistry service providers in the stories, all based in the West, know that Asian contractors are nipping at their heels with capabilities that are growing and costs that are low. In response, Western firms promote the important, but often intangible, qualities of scientific know-how and problem-solving ability. It’s not always enough, but sometimes it’s all they have to distinguish themselves from the competition.