Manufacturing Investment in Puerto Rico - Pharmaceutical Technology

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Manufacturing Investment in Puerto Rico
Puerto Rico seeks to build its standing in biopharmaceutica manufacturing and research as it retains its role in bulk pharmaceutical and dosage manufacturing for small molecules.

Pharmaceutical Technology
Volume 32, Issue 1

Also, the contract manufacturing organization Patheon (Toronto, ON, Canada) announced in December 2007 that it would divest its Carolina, Puerto Rico, facility. The 230,000-ft2 facility manufactures oral cephalosporin solid-dosage forms, including tablets, capsules, and powders for suspension. The Carolina facility manufactures four products on behalf of six clients. Patheon, however, will retain its facilities at Caguas and Manati, Puerto Rico, and plans to improve operating costs, quality and training systems as well as reduce overhead costs.

These plant closures reveal not only changing product sales for individual companies but also reflect a broader shift in pharmaceutical manufacturing from small molecules and solid-dosage forms to biologics.

"We are confronting changes in the pharmaceutical industry such as overcapacity in solid-dosage manufacturing, the transition from the blockbuster drug model to specialty therapeutics and niche markets, and the increased importance of biopharmaceuticals," says Enrique Mirandes, director of life sciences at Pridco. "As a result, we are aggressively pursuing biotechnology manufacturing and research and are putting into place the physical and human capital to make that transformation."

Shift to biologics

The growing importance of biopharmaceuticals in Puerto Rico is evident in several large investments in biopharmaceutical manufacturing and in the commonwealth's strategy to work with public and private sources to attract investment for research in biologics.

In April 2007, Abbott Laboratories (Abbott Park, IL) opened a $450-million, 330,000-ft2 biologics manufacturing facility in Barceloneta, Puerto Rico, to support the long-term supply of its biologic agent, "Humira" (adalimumab). In August 2006, Eli Lilly (Indianapolis, IN) completed a $1-billion expansion of its manufacturing operations in Carolina, Puerto Rico. The investment included new bulk capacity for "Humalog" (insulin lispro [rDNA origin] injection).

Also, BMS is expanding its fill–finish capacity at its facility in Manati, Puerto Rico. The project is targeted for start-up in 2009. The approximately $200-million expansion will add new space and renovate existing space for the filling–finishing of the company's sterile products and biologic compounds, including "Orencia" (abatacept), BMS's first internally developed biologics compound.

BMS is building a new $660-million large-scale, multiproduct bulk biologics manufacturing facility in Devens, Massachusetts for Orencia. The facility is scheduled to be completed in 2009 and brought on line in 2011.

In 2006, Amgen announced plans to invest $1 billion over four years to expand its manufacturing capacity at its facilities in Juncos, Puerto Rico. The plan includes an expansion of bulk-protein manufacturing facilities for "Neupogen" (filgrastim) and "Neulasta" (pegfilgrastim), a new bulk plant for "Epogen" (epoetin alfa) and "Aranesp" (darbepoetin alfa), a new formulation, fill–finish facility, and enhancements to its existing fill–finish plant.

Pridco's Mirandes expects the majority of the project will proceed as planned despite an announcement by Amgen in August 2007 that the company will be implementing a restructuring program aimed of achieving cost savings of $1.0–1.3 billion in 2008. The restructuring reflects decreased revenues and potential further revenue declines for Epogen and Aranesp. The restructuring involves reducing headcount by 12–14%, reducing capital expenditures by $1.9 billion during 2007–2008, and closing certain production facilities. A key target for the cutback in expenditures is in Ireland. Amgen announced in October 2007 that it will postpone indefinitely its $1-billion planned design and build-out of a bulk manufacturing facility in County Cork, Ireland.

BD Biosciences, part of Becton, Dickinson (Franklin Lakes, NJ), invested $53 million to expand its facility in Cayey, Puerto Rico, for producing monoclonal antibody reagents.

Also, Abraxis BioScience (Los Angeles, CA) invested $45 million to add lypholization capacity in the former Pfizer (New York) facility in Barceloneta. Abraxis BioScience purchased the facility from Pfizer in 2006. Abraxis opened the 172,000-ft2 facility in May 2007. The facility produces injectable pharmaceuticals, protein-based biologics, and metered-dose inhalers.


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