TKT suspends production after fire at Massachusetts site

The fire originated on the roof of the facility and was confined largely to the roof, with damage elsewhere limited to water and smoke damage. All employees were safely evacuated from the building and no finished goods or drug substance inventories were lost as a result of the fire.

TKT manufactures bulk drug substance of its protein products, Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease, Iduronate-2-Sulfatase (I2S) for Hunter syndrome, and gene-activated glucocerebrosidase (GA-GCB) for Gaucher disease, at this facility.

Although production has been temporarily suspended, the company said that, based on existing inventory levels, it does not expect any interruption with commercial supplies of Replagal for clinical trials in the near-term.

TKT expects to complete its assessment of the fire’s impact on the facility over the next several days and implement a plan to resume manufacturing at the facility as quickly as possible.