Sanofi and Genzyme receive approval for Waterford expansion

Sanofi and Genzyme have been granted regulatory approval for a second operation for filling and finishing products at its Waterford, Ireland manufacturing plant.

The European Medicines Agency and US Food and Drug Administration have ratified plans to use the site as a means of doubling its ability to fill and finish Myozyme and Lumizyme (alglucosidase alfa) produced at the 4,000-litre bioreactor scale.

Genzyme is also seeking approval from the two regulators to fill and finish additional products in the second suite, which will allow Waterford to be used as a filling and finishing platform across its entire portfolio.

The Irish plant has now been in operation for more than a decade and is considered Sanofi and Genzyme's centre of excellence for aseptic manufacturing, with a $150 million (93.15 million pounds) expansion having been completed earlier this year.

Genzyme's head of global manufacturing operations Bill Aitchison said: "The approval of the second filling and finishing suite in Waterford is another important milestone on our journey to build a robust manufacturing network capable of ensuring reliable and consistent supply of our products."

Last month, the companies reported new trial data for their multiple sclerosis drug Lemtrada, underlining its numerous safety and efficacy benefits.