Sanofi Gains Regulatory Approval for Expansion at Site in Ireland
Sanofi has received FDA and EMA approval for expansion of fill and finish operations for alglucosidase alfa.
Sanofi’s subsidiary Genzyme has received approval from FDA and EMA for a second operation for a fill–finish product at its Waterford, Ireland, manufacturing plant.
With this approval, Genzyme has nearly doubled its ability to fill–finish Myozyme and Lumizyme (alglucosidase alfa) produced at the 4000-L bioreactor scale. Genzyme also will begin the process to secure FDA and EMA approvals to fill–finish additional products in the second suite, with the long-term goal to use the Waterford site as a fill–finish platform across its portfolio of products.
Genzyme’s Waterford facility has been in operation for more than 10 years, and a $150-million expansion was completed earlier this year. The Waterford manufacturing site employs over 500 people and is considered Genzyme’s center of excellence for aseptic manufacturing.
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