The Lyon plant will replace Genzyme’s smaller plant in nearby Marcy l’Etoile and will provide more than twice the manufacturing capacity. Construction is expected to begin later this year, and regulatory approvals are expected starting in 2010. Routine manufacturing at the site is scheduled to commence in 2011. The total cost of the project is expected to amount to E105 million.
The construction of the new 140,000-square-foot facility is a response to the anticipated long-term demand for Thymoglobulin, both for its current use and in potential new indications. Thymoglobulin’s growth has been driven by its launch in new geographic markets and by publications and clinical studies. The product is currently approved in more than 50 countries.
The project represents one of a number of investments Genzyme is making in its global manufacturing infrastructure to support the growth of existing products and to prepare for the introduction of future products from its late-stage pipeline.
In addition to the Lyon project, Genzyme has been engaged in the development of a new plant in Belgium for the production of monoclonal antibodies and proteins and expanding other facilities, including its Allston Landing protein manufacturing plant in Boston. Furthermore, the company also received regulatory approvals for a new filling and packaging facility at its manufacturing site in Ireland, which has become the company’s major European center for the final production and distribution of a range of products, including Thymoglobulin.
Genzyme operates fifteen GMP manufacturing plants around the world, with seven of them in Europe.