Geel, Belgium – Genzyme today announced it will be building a new state-of-the-art biotechnology facility, as part of its Geel manufacturing complex, to further increase worldwide capacity for alglucosidase alfa, the active ingredient of its enzyme replacement therapy for Pompe disease.
This planned €250m extension falls under Genzyme’s previously communicated global investment to support a four-fold increase in overall manufacturing capacity for all its enzyme replacement therapies.
About 150 new jobs will be created as part of the expansion, bringing the total workforce at Geel to nearly 600 people.
The new 22,000m2 building also provides ample room for additional future capacity expansions.
Commercial approvals for the new site are targeted starting in late 2014.
Piet Houwen, General Manager of Genzyme’s Geel manufacturing site, said: “Our presence in Belgium has grown substantially since the opening of the Geel manufacturing site in 2005. Our site has recently received approval for commercial activities by health authorities in Europe, US & Canada, Asia and Latin America, demonstrating its strategic role in Genzyme’s global supply chain.
“Our strong track record of results, along with the expertise and dedication of our workforce and the partnership with local, provincial and regional authorities, have been instrumental in bringing this exciting new investment to Geel.”
Flanders Minister-President Kris Peeters said: “We are happy to support the implementation of Genzyme’s expansion project in Geel.
“As part of our Flanders 2020 objective of making the region a leader in innovation and to advance its prosperity, this new manufacturing center represents a great opportunity for job creation and economic growth.”
“The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission,” said Scott Canute, President, Global Manufacturing and Corporate Operations. “We are committed to delivering a reliable supply of high quality medicines to our patients. This investment ensures continued supply to our patients in the Pompe community for the long term.”
The new facility in Geel will function as a completely independent plant, with the objective of securing sufficient future supply of alglucosidase alfa, known as Lumizyme™ in the US and as Myozyme® in the rest of the world.
The building will contain two additional 4000L bioreactors for the production of alglucosidase alfa, as well as a complete purification installation.
This will bring to five the number of bioreactors dedicated to the production of the therapy, as two bioreactors are already providing global commercial supply for the treatment, and a third is expected to receive its first commercial approvals by the end of 2011.
Genzyme began work on a therapy for Pompe disease ten years ago, and the company has invested nearly $1 billion to support the development program.
Pompe disease is a progressive, debilitating and often fatal neuromuscular disease caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA).
This enzymatic defect results in the accumulation of glycogen primarily in muscle tissues that leads to muscle weakness, loss of respiratory function, and often premature death.
When symptoms occur in infancy, babies typically die within the first year of life.
When symptoms occur in childhood or adulthood, patients typically lose their ability to walk and require wheelchairs to assist with mobility and experience difficulty breathing as well as mechanical ventilation to breathe.