BMS, Novo Nordisk, and Roche Proceed with Manufacturing Expansions

Devens, MA, Montes Claros, Brazil, and Florence, SC (May 2)-Bristol-Myers Squibb Company (BMS, New York, NY, www.bms.com), Novo Nordisk A/S ( Bagsværd, Denmark, www.novonordisk.com), and Roche (Basel, Switzerland, www.roche.com) provided updates to their companies’ respective manufacturing expansions. 

BMS breaks ground on biologics facility

BMS broke ground on Wednesday for its $750-million biologics manufacturing facility in Devens, Massachusetts. The $750-million investment is BMS’s single largest capital investment in its history.

The new, large-scale, multiproduct bulk facility is modular in design to accommodate potential future expansion. Phase I of the project calls for the construction of four main buildings: a manufacturing structure that will house six 20,000-L cell-culture vessels and one purification train; a central utility building; an administrative and quality-control building; and a warehouse and storage structure. The facility is projected to be operationally complete in 2009, and BMS plans to submit the site for regulatory approval in 2010.

Phase I of the facility will require a workforce of approximately 350 employees. Future expansion of the site, including several additional buildings, could lead to a total of 550 or more employees. Any expansion will depend on the demand for BMS’s biologic drugs and regulatory approval of investigational compounds.

The facility will support increased production capacity for “Orcencia” (abatacept), BMS’s first internally discovered and developed biologic medicine, and also will manufacture commercial quantities of compounds currently in development should those compounds receive regulatory approval

BMS currently manufactures biologic compounds in a company-owned facility in Syracuse, New York, and finishes and packages biologic compounds in Manati, Puerto Rico. The Syracuse site was not designed to accommodate large-scale commercial production but  will continue to serve as a center in process development and early-product launch for BMS’s biologic compounds.

The Manati facility, which also is wholly owned by the company, will continue to finish and package biologic compounds. In March 2006, the company announced a $200-million investment to expand this facility to accommodate increased filling and finishing needs.

Bristol-Myers Squibb also has biologic manufacturing agreements with third-party partners Lonza Biologics Inc. (Basel, Switzerland, www.lonza.com) and Celltrion, Inc. (Incheon, Korea, www.celltrion.com).

Novo Nordisk opens insulin plant in Brazil

Novo Nordisk inaugurated a $200-million expansion of its production facilities in Montes Claros, Brazil. The 37,000-m² plant will formulate and fill insulin into 3-mL “Penfill” cartridges, which are used in the pen systems marketed by Novo Nordisk. Approximately 95% of the total volume produced in the Montes Claros plant will be exported to other countries such as Germany, Austria, the United Kingdom, Ireland, Australia, New Zealand, Canada, and later on to several developing countries. Novo Nordisk expects to increase the number of employees at the site from the current 400 to 750 by the end of the year.

The new plant is Novo Nordisk’s largest manufac­turing facility outside Denmark and is the largest single investment in the history of the pharmaceutical industry in Brazil, said Novo Nordisk in a company release

Novo Nordisk also recently approved an additional investment of $50 million for the construction of a manufacturing facility in Montes Claros for “FlexPen,”a prefilled insulin pen. The new FlexPen facility is expected to become operational by 2009.

Roche plans expansion of South Carolina facility

Roche Carolina Inc. (RCI), a pharmaceutical process development and bulk active ingredient manufacturing affiliate of Roche Holding Ltd., plans to expand its pharmaceutical manufacturing facility in Florence, South Carolina. The $60-million investment will involve the construction of a new multipurpose production unit in an existing manufacturing building. Roche also plans to add 25–30 new positions at the facility. Construction is scheduled to begin in mid-2007 with completion slated by the end of 2008.