New biologics facility for BMS
plot of land to build a new bulk biologics manufacturing facility
in Devens, Massachusetts.
The company has earmarked $660m for the construction of the new facility, with building work expected to begin in the next few weeks. If all goes well the site should be ready for operation in 2009, and the company plans to submit the site for regulatory approval in 2010 ready for commercial production to begin in 2011.
Despite original plans for construction of the plant to begin in September last year, the company maintains its original timelines for completion of the facility.
The new site is intended to support increased production capacity of biologic compounds such as the company's Orencia (abatacept) for rheumatoid arthritis, as well as new biological products in development.
Bristol-Myers Squibb currently uses its Syracuse, New York facility and third party manufacturers to produce its biological products, with finishing and packaging taking place at the firm's Puerto Rico site.
"The Syracuse facility was never intended to produce commercial quantities of biologic medicines," Jeff Macdonald of BMS told In-PharmaTechnologist.com.
"Rather it is a centre of excellence for manufacturing process and also has capacity to produce quantities suitable for R&D purposes."
The company maintains that its current internal and external biologics resources will remain important features in its strategy to expand its biologics portfolio. In March last year the company invested $200m in the Puerto Rico facility to fund an expansion to accommodate increased filling and finishing needs.
BMS currently has manufacturing agreements with Swiss firm Lonza and Celltrion, with approval for the manufacture of Orencia (abatacept) at Lonza's facility in New Hampshire, and Macdonald confirmed that these partnerships will continue.
On announcing the proposed expansion in June last year, Peter Dolan, BMS CEO, said that the investment in the new facility "represents a significant commitment towards increasing manufacturing capacity so that we can meet future market demand and research production needs for the company's biologic compounds."
The company's first approval for a biologic was granted in 2004, with approval for its first internally discovered and developed biologic (Orencia) in 2005. In 2006 Orencia achieved worldwide net sales of $89m.
BMS is keen to become increasingly involved in the growing biologicals market, and has initiated a strategy including technology acquisitions, licensing opportunities and in-house development in a bid to expand its biologicals capability. The company currently has biological compounds in development, including a Phase II trial for delatacept for solid organ transplant rejection, as well as other potential oncology therapies.
Biologicals represent one of the fastest growing sectors of the pharmaceutical industry, with annual sales of biologics predicted to increase by $26bn by 2010, in contrast to the $13bn increase estimated for small molecules.
