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Chitra Sethi, Managing Editor, BioPharm International
Genzyme (Cambridge, MA) will outsource fill-and-finish operations for its drugs Cerezyme, Fabrazyme, Myozyme, and Thyrogen to Illinois-based Hospira, Inc.
Genzyme (Cambridge, MA) will outsource fill-and-finish operations for its drugs Cerezyme, Fabrazyme, Myozyme, and Thyrogen to Illinois-based Hospira, Inc. The move follows a series of manufacturing problems at Genzyme's Allston Landing facility in Boston, MA.
The Allston Landing plant was temporarily shut down last summer for decontamination following the detection of bioreactor contamination with Vesivirus. That shutdown led to shortages of Cerezyme and Fabryzyme.
Then in November, the FDA warned healthcare professionals about the potential for foreign particle contamination of Genzyme products Cerezyme, Fabrazyme, Myozyme, Thyrogen, Lumizyme, and Aldurazyme.
Since last fall, Genzyme has moved some of its fill-and-finish operations to its plant in Waterford, Ireland. The rest will be outsourced to Hospira. The transfer to Hospira is expected to take six to eight months, over which period Genzyme will seek regulatory approval.
Per Genzyme's December 28 filing with the United States Securities and Exchange Commission, the initial term of the agreement will expire on December 31, 2015, followed by a two-year extension.