Roche ($RHHBY) has a taken a hands-on approach with regulating its contractors, installing staff at each of its CMOs to ensure sterility and protect against the third-party manufacturing problems that have cost its competitors time and money.
As FiercePharmaManufacturing reports, Roche has instituted what it calls the Sterile Oversight Strategy, in which it keeps a close eye on its contractors to ensure plant management, environmental control and equipment reliability. The company also has proprietary software that collects monthly reports from CMOs, and the drugmaker isn't shy about destroying whole batches if they slip below its high standards.
Such dedication is an expensive proposition, Roche said, and the company is scaling back the number of CMOs it uses, paring down to a core group that can absorb the higher cost in the interest of pleasing a big-name client with track record of success.
It's not hard to see the thinking behind Roche's high emphasis on CMO reliability. Over the past year, competitors GlaxoSmithKline ($GSK) and Allergan ($AGN) have been burned by problems with contract manufacturers. GSK is now facing a shortage of Horizant, its restless leg syndrome treatment, thanks to an unspecified problem with a CMO. And the FDA has delayed approval for migraine treatment Levadex after problems at an inhaler plant operated by contract manufacturer Exemplar Pharma.
Same goes for Navidea Biopharmaceuticals ($NAVB), which took a beating from investors after the FDA delayed approval of the Lymphoseek diagnostic tool due to third-party manufacturing issues. The company has since partnered with Canadian manufacturer Nordion ($NDZ), hoping to avoid future production setbacks.
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