FDA’s and EMA’s January inspection clearance of Genzyme’s new production facility in Framingham, Massachusetts marks another significant step in the firm’s recovery process from a viral contamination and GMP compliance problems cited in a consent decree.
In its new production facility, Genzyme has implemented manufacturing designs and systems developed from the lessons learned in the long wake of the viral contamination it experienced in 2009 at its Allston, Massachusetts plant and the consent decree that followed on the heels of the contamination and a pair of adverse inspections (IPQ “In the News” May 28, 2010).
The 2009 Allston shutdown halted Genzyme’s production of its Fabry disease recombinant enzyme Fabrazyme (agalsidase beta) exacerbating existing shortages of the drug. Supply problems began to surface in 2008 stemming from production titer declines later found to be associated with viral contamination.
Production of Fabrazyme will now take place at the Framingham facility and help to alleviate a shortage of the drug that was exacerbated by the shutdown.
Genzyme CEO David Meeker said in a press release that the approvals keep Genzyme on track with its 2012 plan “to restore unconstrained [Fabrazyme] supply for all patients globally throughout the course of the year.”
The return to normal supply levels of Fabrazyme is planned to begin in the second quarter and continue throughout the year as Genzyme works to obtain regulatory approvals in other global markets and to build inventory.
[More on the Genzyme contamination experience, a comparison with viral contamination events also over the last few years at Amgen and Merrimack, and advice by CDER biotech expert Barry Cherney on virus control is provided for subscribers here. Nonsubscribers can purchase the 7,000 word story for $195 by contacting Peter Blachly (firstname.lastname@example.org). For subscription/license information, click here.]
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IPQ Report, May/June 2009 Special Report on trends in FDA and EU enforcement activities