Genzyme boosts capacity following green light for Waterford plant
pharmafile | May 8, 2012 | News story | Manufacturing and Production |Â Â EMA, FDA, Genzyme, Sanofi, WaterfordÂ
Sanofi subsidiary Genzyme has doubled its capacity to fill-and-finish two of its drugs for rare disorders following approval of a second production suite in Waterford, Ireland by US and EU regulators.
The approvals are another key stage in Genzyme’s recovery from the manufacturing problems that have affected its rare treatment disease business in the last couple of years, prompted by a contamination issue at its Allston Landing plant in the US which led to shortages of several drugs.
The company officially opened a €150 million expansion at the ten-year-old Waterford facility last year, with the aim of tripling its fill/finish capacity and alleviating the shortages by allowing material to be completed away from Allston Landing.
The approvals from the FDA and European Medicines Agency (EMA) have ‘nearly doubled’ Genzyme’s ability to fill and finish Myozyme/Lumizyme (algucosidase alfa) products for Pompe disease produced at the 4,000 litre bioreactor scale.
Genzyme said it will also begin the process to secure FDA and EMA approvals to fill and finish additional products in the second suite, with the long-term goal to use the Waterford site as a filling and finishing platform across its portfolio of products.
Genzyme has also been transferring manufacturing from Allston Landing to another site in Framingham, Massachusetts, and won FDA approval to make its Fabrazyme (agalsidase beta) product in the new facility earlier this year.
It is also in the process of constructing a new plant in Geel, Belgium, to boost capacity to produce the active ingredient in Myozyme/Lumizyme as part of an ongoing project to increase its manufacturing capacity for biologics four-fold.
Waterford has seen capital investment of around €500 million since it was set up, and the latest funding has gone towards increasing capacity at the company’s biologics sterile finishing operation, with added development capability, laboratory facilities and administration offices.
Phil Taylor
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