The US biopharmaceutical company is investing €105m to build a new 140,000 sq ft. manufacturing facility in Lyon, which will replace Genzyme's smaller plant in nearby Marcy l'Etoile and will provide more than twice the manufacturing capacity.
The facility is being built to meet the anticipated long-term demand of thymoglobulin, both for its current use as a treatment in organ transplantation and in potential new applications such as for haematological disorders and autoimmune diseases.
"The demand for Thymoglobulin is growing, so we need to have the capacity to meet that, but we also anticipate that the demand could be even greater if Thymoglobulin is approved for potential other applications such as diabetes," a Genzyme spokeswoman told in-PharmaTechnologist.com.
Thymoglobulin is a polyclonal antibody extracted from rabbit serum used to treat or prevent acute rejection in various transplant recipients and to treat severe or steroid-resistant acute rejection in kidney transplant patients and in the treatment of aplastic anaemia.
The market for the drug in 2004 was in excess of $90m (€67m), and Genzyme sales last year increased 17 per cent to $149m. The move to build a new facility also reflected the company's drive to increase its global manufacturing infrastructure to support its growth of current products and to prepare for the introduction of future ones.
Genzyme is completing the development of a new plant in Belgium for the production of monoclonal antibody Mabcampath (alemtuzumab) and proteins, while expanding other facilities, including its Allston Landing protein manufacturing plant in Boston.
The company has also recently finished a new filing and packaging facility at its manufacturing site in Ireland, which has become the company's major European centre for the final production and distribution of a range of products, including thymoglobulin.
The Genzyme investment in France, where the company has been present since the early 1990s, would help to strengthen partnerships in the region, the spokeswoman said.
"Since the beginning, we have worked on building a strong global presence to ensure that we can reliably and consistently meet the needs of our patients, regardless of their geographical presence.
To ensure a steady supply of products for patients and to be able to react to increases in demand, we have been working to increase our ability to manufacture individual products at more than one site."
The new plant will be located on a nine-ache site within the Lyon-Gerland Biopole, an area dedicated to biotechnology, with the possibility of future expansion.
Construction is expected to begin later this year, with regulatory approvals expected to start in 2010 and routine manufacturing to commence in 2011.
Genzyme senior vice president for corporate operations Mark Bamforth said in a statement: "As with our other new facilities, we intend the Lyon plant to serve as a highly visible expression of Genzyme's purpose, which is to innovate and set new standards in both the products that we develop for patients and in the way we operate as a company."
Genzyme intends to develop the French site using a High Environmental Quality (HEQ) approach and to obtain HEQ certification by meeting or exceeding standards set by the Centre for Scientific and Technical Building.
The plant would be one of the first manufacturing sites in France to gain HEQ certification.
Genzyme has 17 manufacturing sites spread across three continents, eight of which are in Europe.
Thymoglobulin has marketing authorisation in most EU countries, with the first approval granted in 1984 in France.
Genzyme acquired the product through the acquisition of Sangstat Medical Corporation in 2003.