Virus stops production at Genzyme's Allston Landing plant

Genzyme Corporation has halted production at its Allston Landing manufacturing facility in MA, US after identifying a virus in the bioreactor that produces Cerezyme (imiglucerase for injection). The production of Fabrazyme (agalsidase beta) has also been interrupted while the plant is sanitised.

Following discussions with the US FDA and European EMEA, Genzyme has begun shipping product from finished lots of Cerezyme held in inventory, after PCR testing detected no evidence of Vesivirus 2117. Shipments of Fabrazyme were not put on hold.

"We continue to make strong progress toward resolving this situation as quickly as possible," said Henri Termeer, Genzyme's chairman and chief executive. "We are confident that the Allston plant will be back online later next month, that we will be able to minimise the impact of constrained supply, and that the measures we are implementing will prevent this issue from occurring again."

Because stocks of Cerezyme and Fabrazyme are not sufficient to avoid shortages during the period of suspended production and recovery, Genzyme is to manage product supply, with the aim of protecting the most vulnerable patients.

Genzyme is following a well-established method for removing viruses at the Allston plant, which includes disassembly and removal of equipment, cleaning, disinfection of cell culture and downstream production suites with vaporous hydrogen peroxide, installation of new air filters and insulation, and other measures.

The company will complete this work and restore operations by the end of July.

The company currently expects to have to limit the supply of each product for approximately 6-8 weeks.

Genzyme has confirmed that Vesivirus 2117 also contaminated production twice in 2008, once at the Allston plant and once at the company's biologics plant in Belgium. Although Genzyme was not able to detect and identify the virus until this year after it developed a highly specific assay, it took precautionary measures in 2008 and sanitised both facilities.

Genzyme says it is likely that the virus was introduced through a raw material used in the manufacturing process, and it is collaborating with its suppliers to address this issue and implement steps to protect against recurrence.

Genzyme is also evaluating adding steps to its raw materials screening and virus removal processes to make them more robust, including testing all raw materials for the presence of Vesivirus 2117 using the highly specific assay.

Genzyme has been operating with lower than usual inventories of Cerezyme and Fabrazyme because it has allocated capacity for Myozyme (alglucosidase alfa) production at the Allston plant owing to strong growth of the product worldwide.

The company recently received EU approval to manufacture Myozyme at the 4000-litre bioreactor scale at its plant in Belgium. The company is in the process of transitioning all Myozyme production to this plant, which is currently being expanded with the addition of a third 4000-litre bioreactor, scheduled to come on line in 2011. This will bring Genzyme's total investment in the plant to nearly US$500m since 2001.

In addition, Genzyme is in the late stages of building a new US$300m plant in Framingham, Massachusetts, for the production of Cerezyme and Fabrazyme. This plant, which will include four 2000-litre bioreactors, will provide substantial additional capacity to support the growth of the two products. The company anticipates starting qualification runs next year and receiving regulatory approval for the production of Fabrazyme in 2011 and for the production of Cerezyme in 2012.