Bristol-Myers Squibb, Manatí, Puerto Rico

In 2006 Bristol-Myers Squibb announced a major investment of $220m (€176m) for the expansion of its biologics manufacturing plant in Manatí, Puerto Rico. The company has four plants in Puerto Rico in total.

The plant, which already manufactures and packages a number of biologic products through its fill and finish facilities, is now set to contribute to the production of the new BMS treatment for moderate to severe rheumatoid arthritis, Orencia (abatacept) (produced from Chinese hamster ovary cells) and also some investigational compounds.

The centre for Orencia production is Syracuse, New York in the US and BMS has also contracted some of the production capacity out to Lonza; Lonza was given FDA permission to produce Orencia in May 2006.

Additional capacity requirement for Orencia production meant the expansion of Manatí, BMS's only biologics facility in Puerto Rico. This facility also produces three other important biologic products for BMS: Coumadin, Sustiva and Cardiolite.

The project to expand the plant started in 2007 and is expected to take two years including commissioning/validation.

EXPANSION

The Bristol-Myers Squibb expansion at Manatí will add around 100,000ft² of new space to the plant and will also renovate a further 30,000ft² of existing space for filling and finishing of sterile products (disposable syringes) and biologic compounds, including Orencia (abatacept).

Carlo de Notaristefani, president of technical operations for BMS, commented: "The investment in Manatí will build on the site's existing technical strength and experience in biologics, and demonstrates BMS's commitment to increasing our in-house sterile manufacturing capacity as well as to our local partners in site locations such as Puerto Rico.

"Our manufacturing strategy involves a combination of expanding our own internal biologic production capacity, and strategic partnerships with third-party suppliers."

Manatí currently employs 370 personnel, but with expansion of biologics production and fill and finish facilities there will be a need for extra staff.

The construction work has required an extra 700 workers and commissioning will see 200 additional consultants on-site. Manatí has been put forward as the centre for biologics production in Puerto Rico, with additional investment promised after the current expansion.

CLOSURE

In October 2007 BMS announced the closure of one of its plants in western Puerto Rico. The closing plant, which has been in operation for 36 years, makes Pravachol for heart disease and Glucophage for diabetes, as well as Abilify to treat bipolar disorders and schizophrenia.

The closure will see 400 jobs lost and will occur in stages through to 2008. Abilify production will be switched to another production plant in Puerto Rico, possibly Manatí. The other two drugs are having production scaled down due to lack of demand, probably because of the availability of generic versions.

CONSTRUCTION

The general construction work for the expansion project has been carried out by Mar-Land Industrial Contractors Inc of Puerto Rico. The work has included foundations, and also construction work and interior first fitting. The construction management for the project was provided by Torcon Inc of Guayanobo, Puerto Rico. Benjamín Soto & Associates (BSA) was involved in the commissioning of the new fill and finish facilities in the 30,000ft² renovation part of the project.

ABATACEPT (ORENCIA)

Orencia is a compound used to treat rheumatoid arthritis when tumour necrosis factor α inhibitors do not work. The treatment is a fusion protein that is made up of an immunoglobulin fused to the extracellular domain of CTLA-4, which is a molecule capable of binding the B7 receptor.

Orencia functions as a selective co-stimulation modulator as it inhibits the co-stimulation of T cells to mediate and control the inflammatory response targets; the drug targets CD28, preventing the interaction with CD80/86 on antigen-presenting cells. The drug is given in solid dosage form but not in combination with any other drug.

Orencia was launched in the UK in June 2007 but the National Institute for Health and Clinical Excellence (NICE) rejected the drug in August 2007 as not being cost effective. However, a review may still overturn this verdict. The drug is selling well in the US market and the problem with the UK market is not expected to prevent the drug from achieving blockbuster status.