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The classic pharmaceutical outsourcing story is about how a biotech start-up hires a contract manufacturer to execute the multistep synthesis of a complex small-molecule drug. Fancy catalysts are brandished. Tricky separations are pulled off.
Those stories can still be told. Read on for the tale of Theracos’s relationship with Piramal Pharma Solutions on the manufacture of the investigational diabetes treatment bexagliflozin.
Increasingly, though, contract manufacturers are making other kinds of molecules. For example, biologic drugs such as Humira are made by fermentation in mammalian cells or in an organism such as yeast. A contract manufacturing business is also emerging in gene therapies delivered by viral vectors.
Not as fast growing but still important are naturally derived products from the sea and the land. Acasti Pharma is developing a new member of a lucrative class of omega-3 fatty acid heart drugs that are extracted from fish or krill.
And poppy-derived opioids, while controversial and highly regulated, continue to be a big business. Owing to regulations, a bulk narcotics company that wants to enter a foreign market might need to find a contractor in the target country. That’s what Australia’s TPI Enterprises did when it hired Sterling Pharma Solutions in the U.K.
Ideas for innovative pharmaceuticals continue to come from the sea and land—as well as the blue sky of the scientist’s mind. Transforming them into a molecule that can be approved often requires an outsourcing partner schooled in the right pharmaceutical art.