Kudos to Margaret Poole, the new Genzyme senior VP and site leader at the embattled Allston Landing facility just outside Boston, for getting the plant back on line. Poole says in a Boston Globe report that "no effort will be spared to prevent another virus from contaminating the plant," and that the plant cleanup represents a remediation program that the company will use at all its biologics facilities.
She adds that the company has designed tools to test for the facility-crippling virus and to scan incoming raw materials, the likely source of the virus. It has also begun segregating personnel and equipment in the cell culture prep area from other production areas.
Poole will also oversee a plant now under construction in nearby Framingham, which is slated to make Cerezyme and Fabrazyme, for Gaucher disease and Fabry disease, respectively, to augment supplies from theit chief manufacturing site, Allston Landing.
As important a milestone as it is, completion of the cleanup and restart of the six bioreactors is an early step in the plant's recovery. European inspectors in late August identified "a major observation and several other observations" to which the company must respond, says a Genzyme announcement. And the FDA, which began voicing its issues with the plant in February--four months before the viral-contamination shutdown--has yet to return.
The company says it remains on schedule to begin releasing the first lots of Cerezyme and Fabrazyme from the plant in November and December. But the biotech giant can hear the footsteps of drugmakers Shire and Protalix Biotherapeutics, which recently received an FDA boost to their Gaucher disease products through a prescribing OK prior to commercial approval, says MarketWatch. The FDA took the action to shore up dwindling supplies.
The Protalix drug is noteworthy because of its production via plant cells rather than the animal cells used in both the Genzyme and Shire processes. Protalix says that its drug is not susceptible to the viral contamination that shut down Genzyme manufacturing.