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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.