Revalidation of fill/finish equipment caused the delay in Thyrogen shipping that we reported last week, not faulty equipment. The revalidation is standard within good manufacturing practices, says Genzyme ($GENZ) spokesperson Erin Emlock.
Fill/finish is the only part of Thyrogen production that takes place at Genzyme's Allston Landing site. The cancer treatment is manufactured at a plant in Framingham, MA, some 20 miles west of the Boston-area facility. Genzyme is in the process of moving the drug's fill/finish operation out of the Allston site in accordance with the consent decree, Emlock says in an email.
Separately, after watching Genzyme suitor Sanofi ($SNY) struggle with Shan5 vaccine manufacturing issues after contamination halted production, analyst Michael Leacock says he "remains to be convinced" that Sanofi can add value in resolving Genzyme's manufacturing overhaul. Bloomberg quotes Leacock at the end of August informing clients that production difficulties remain.
Sanofi purchased Shantha in 2009. The WHO, which had contracted Shantha to supply the childhood disease prophylactic through 2012, temporarily suspended production when white sediment was found in the vaccine. WHO got the vaccine from other sources, and Sanofi lost out on $340 million in revenue.
- see the Bloomberg report