Fabrazyme falls victim to fill/finish

More fill/finish trouble for Genzyme ($GENZ) at its Boston-area plant: this time, it's Fabrazyme. The production setback promises to extend an existing shortage of the Fabry disease treatment.

One lot of the drug was rejected due to a "quality issue," according to a Genzyme spokesperson, based on "environmental monitoring findings," says the Wall Street Journal. Bulk production, however, is not affected.

The rejected lot was destined for overseas distribution. But Genzyme has revised plans and is spreading the shortage across all markets.

Just last week, a fill/finish problem with Thyrogen, its thyroid cancer treatment, led to announcements of likely shortages through July. And last fall, revalidation of fill/finish equipment slowed Thyrogen distribution.

Fill/finish operations are a topic in Genzyme's consent decree with the FDA. The company has been working toward ending the final-stage operation at the Allston Landing plant by dispatching the tasks to another of its facilities in Massachusetts and to contractors.

- here's the story from the WSJ
- read the Boston Globe article
- and see the Boston Business Journal piece


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