Issue Date: March 12, 2012
Small and Start-up pharmaceutical companies must juggle a lot of balls as they move potential drugs toward the market. They are conducting animal and human trials of their compounds. They are meting out cash carefully while courting investors for more funds. And they are looking ahead to potential big pharma partners in the fortunate event that the trials are successful and their drugs show commercial potential.
The last thing these companies want to worry about is the manufacture of the active ingredients in their drugs. That’s what they count on contract manufacturing organizations to do for them. They want an outsourcing partner that can improve process chemistry and scale up production without a lot of hand-holding or guidance.
On the pages that follow, C&EN presents case studies of three pharmaceutical outsourcing partnerships. In all three cases, a small or start-up drug company with limited resources is relying on a contract manufacturer to produce an active pharmaceutical ingredient for clinical trials with precision, speed, and economy.
Genmab, the biotech firm featured in the first case study, once had 555 employees and big plans to manufacture its own antibodies. Now it has fewer than 200 employees and is trying to sell its manufacturing facility. Not surprisingly, Genmab is counting on its outsourcing partner, Lonza, for much assistance.
In the second study, the less-than-three-year-old biotech firm Euthymics Bioscience chose Cambridge Major Laboratories to manufacture the active ingredient in its developmental depression drug. For Euthymics’ head of technical operations, technical prowess was not enough. He wanted a company that could also bring some business savvy to process development. With a staff of just 10 people, Euthymics needs the helping hands.
Probiodrug, the German drug company featured in the third case study, is 15 years old—mature by biotech standards. But it still has no employees versed in process scale-up or manufacturing under current Good Manufacturing Practices conditions. After a search for a nearby firm that could provide these skills, it chose the Swiss firm Carbogen Amcis and has since been rewarded with a much-improved synthetic route.
Managers at Carbogen and the other chemistry providers know that their contracts are not forever. The dream of many biotech executives is for their firm to partner with, or get acquired by, a big pharmaceutical company—one that will likely want to bring manufacturing in-house. But until that happens, biotechs need all the help they can get.
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