Genzyme achieved its goal of building a small inventory buffer during the first quarter. The current shipping allocation of 50 percent of demand will be extended, however, due to an interruption in operations at the company’s Allston facility late in the quarter. The interruption resulted from an unexpected city electrical power failure that compounded issues with the plant’s water system, which have been corrected. The facility is fully operational. Genzyme estimates that it will need to continue the 50 percent shipping allocation for 2-3 months. The company will provide a more precise supply update within a month, after determining whether Cerezyme material that was unfinished when the interruption occurred can be finished, the impact of the pending consent decree on product release timelines and a more accurate assessment of global demand.
Genzyme will continue to work with minimal levels of inventory for Cerezyme and Fabrazyme until the company’s new Framingham manufacturing facility is approved, which is anticipated to take place in late 2011, and any additional manufacturing delays will likely impact supply of these products.
Across the company’s manufacturing operations, programs to expand capacity are on-track. The new Framingham plant is mechanically complete. Pre-operational activities, including cell culture, media preparation, bioreactor validation and staff training, are currently taking place. Engineering and process validation runs are planned for this year. At its Geel, Belgium facility, Genzyme is adding a third bioreactor for the production of Myozyme, and approval is anticipated in mid-2011. The company is also working to transition fill/finish operations out of its Allston facility to its Waterford, Ireland plant and to a contract manufacturer.