Big bucks for BMS biologics base

Construction has finally begun on Bristol-Myers Squibb's (BMS) new biologics manufacturing facility in Massachusetts, with the company upping its original investment estimates for construction from $660m (€485.7m) to $750m.

The project represents the single largest capital investment in the history of the company, according to BMS CEO Jim Cornelius, and is said to reflect the growing role the company believes biologics will play in the future of the company.

The firm has previously estimated potential long-term investments in the site to reach as much as $1.1bn.

Despite the $90m jump in the budget, a spokesperson for the company said that there was no single factor responsible for the increase, and the it was always expected that original estimate would fluctuate somewhat once BMS had a better sense of the scope of the project.

Although original plans were for construction of the plant to begin in September last year, in February the company was still confident that its original time scales would still be met, with submission for regulatory approval timed for 2010 and operations at the site beginning in 2011.

The large-scale manufacturing plant in Devens, Massachusetts will be a multi-product bulk facility that is modular in design so as to accommodate any future expansion.

The first phase of construction will involve four main buildings, including the manufacturing structure which will house six 20,000-litre cell culture vessels and one purification train.

The facilities are due to be operationally complete in 2009.

The facility is being built to accommodate the production of BMS's popular rheumatoid arthritis medication Orencia (abatacept), first approved back in 2005 and generating worldwide net sales of $89m for the company in 2006.

The company's biologic drugs are currently manufactured at its Syracuse, New York facility, with finishing and packaging taking place in Manati Puerto Rico.

However, the New York facility was never intended for use as a commercial manufacturing facility and despite pulling in third party manufacturers (in the form of Lonza and Celltrion) to help with Orencia production, the dedicated biologics facility with accommodate increased demand for the drug.

When we spoke to BMS back in February when the location of the new facility was finally announced, the company maintained that the contract manufacturing agreements with Lonza and Celltrion would still stand.

The Puerto Rico facility, which last year benefited from a $200m expansion to accommodate increased filling andfinishing requirements, will continue to finish and package biologic compounds.

Alongside increased production capacity for Orencia, BMS intends the new plant to facilitate manufacture of commercial quantities of compounds currently in development and hoped to gain regulatory approval.

At present the company has several biologics in development, including belatacept for solid organ transplant rejection and potential compounds for certain types of cancer.

When BMS originally announced plans for a US biologics facility back in June 2006, four states battled it out to win favour with the company, offering a variety of incentives including tax breaks and less regulatory burden.

Massachusetts won out in the end, beating off rivals New York, North Carolina and Rhode Island to be the new site for the new facility, where at least 350 (and possibly over 550) people will be employed.