Genzyme paying big for GMP slips

For those who may sometimes think that manufacturing operations are hands-on work removed from the high-falutin' business of the executive suite, take a good look at Genzyme. Whether the manufacturing team had a momentary lapse, or the company's creaky manufacturing infrastructure began its inevitable crumble, manufacturing matters at the Boston area plant are what has driven both the company and its long-time leader to the edge.

To a corporate executive, the situation can't get much worse than when Carl Icahn starts planning his path, with friends, to your board, as the New York Times reported Tuesday. Genzyme has scrambled to correct its manufacturing problems, which began in the fall of 2008, by hiring consultants and working with the FDA to bring the plant back up to snuff. And it's farmed out work and moved production to its other facilities to keep business going, even after competitors were granted early market access by FDA to fill a shortage of its specialty drugs.

Its ops restructuring, especially the placement of Eli Lilly manufacturing vet Scott Canute as president of global manufacturing and Sandra Poole as senior VP and site leader at the embattled facility, are moves that can serve the company well for a long time to come. But only if Genzyme and Termeer remain as innovative as they have been for nearly 30 years.

- here's the Times article
- see our coverage of Genzyme's manufacturing issues
- here's our GMP violations coverage