Following contamination issues at its Allston Landing, Massachusetts plant which resulted in a worldwide shortage and $175m fine, the Sanofi subsidiary moved its Fabrazyme (agalsidase beta) manufacturing operations to the newly built nearby Framingham facility.
Now the firm is preparing for anticipated growth in demand for the drug, expanding its purification capacity with a new plant adjacent to Framington.
Genzyme spokesperson David Murdoch told Biopharma-Reporter.com “We anticipate identifying more patients and increasing access in the markets we serve.”
This new plant, he told us, “will offer downstream processing for Fabrazyme bulk drug substance” involving the purification of material harvested from the cell culture manufacturing process which, for Fabrazyme ,takes place in the Framingham, facility next door.”
Fabrazyme Shortage Over
Fabrazyme is an enzyme replacement therapy first approved in 2003 in order to treat the inherited disorder Fabry Disease - a deficiency of the enzyme alpha galactosidase A - and costs approximately $200,000 per year.
Subjected to a number of bottlenecks in its production stemming from the troubled Allston Landing site, the company was at one time running at production level of 30% of the demand for the drug, leading to severe shortages and a petition by patients to force Genzyme to break the drug’s patent.
We asked Murdoch if the shortage issue was still ongoing. “Supply was restored last year following approval of the new Framingham manufacturing plant,” he said, which saw bottlenecks relieved and - according to parent company Sanofi’s CEO Chris Viebacher at the time - output increased without “increasing the number of bioreactors.”
Furthermore fill/finish capabilities for Fabrazyme - along with a Thyrogen, Cerezyme and Myozyme - were transferred to Genzyme’s Waterford, Ireland site in 2010, with a new vial filling line installed last year.