Abbott Laboratories Biotech Facility Barceloneta, Puerto Rico

Puerto Rico has a growing reputation as a biotech and pharmaceutical hub ('Bio Island') and plays host to manufacturing facilities from some of the world's largest pharmaceutical companies. Puerto Rico-based facilities manufacture 13 of the 20 best selling drugs in the US, including Lipitor from Pfizer and Procrit/Eprex by Johnson & Johnson.

One of the latest additions to the biotech manufacturing capacity on the island is the new Abbott Laboratories biotech facility in Barceloneta that was opened in April 2007; Abbott already has an established presence on the island.

The new biologics facility is configured to manufacture one of the latest biologic compounds to hit the market, Humira (adalimumab), a CAT-derived human anti-TNFα (tumour necrosis factor α) monoclonal antibody.

Humira is used to treat a variety of conditions including psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and as a self-administered treatment for severe Crohn's disease. It was approved in Europe in April 2007.

It remains to be seen what other immune system-related diseases Humira will be used for but so far it has proved itself as a valuable drug.

THE PROJECT

The new Abbott facility in Puerto Rico is called Abbott Biotechnology Ltd (ABL). In February 2007 it was approved by the US FDA to carry on the commercial production of Humira for the US market. The new facility was opened to support the large-scale production of Humira as well as undertaking the commercial development of other biologic agents in the Abbott pipeline.

Lawrence Kraus, vice president of manufacturing, global pharmaceutical operations for Abbott Laboratories, commented: "This new facility is a key milestone for Abbott as we move to focus our resources and future growth on biologic and potent-drug manufacturing.

"The advanced, high-quality infrastructure of ABL can meet the exceptionally challenging and stringent processes of biologic manufacturing. With this state-of-the-art facility, we can supply Humira to the growing number of patients who have come to rely on this breakthrough product."

NEW FACILITY

The new 333,000ft² plant required an investment by Abbott of around $450m and has been designed for large-scale production of biologic compounds. The new plant has taken over as the main production centre for Humira from the Abbott Bioresearch Center in Worcester, Massachusetts, US.

The old production site will serve as a production facility for Humira in a supporting role. It will also serve as a research centre and will focus on the company's increasing biologics research and development portfolio.

The new facility has adopted a system of being an entirely paperless manufacturing centre. All of the plant's documentation is produced electronically by using computers, clean room work stations and also secure, wireless connectivity to exchange all the required data. This system will decrease the potential for human error and will make data easier to access at a moment's notice, thus streamlining the documentation process.

CONTRACTORS

Contractors involved in the construction and outfitting of the facility include Insulation Specialties of Barceloneta, Pharmabio, LG Scott (architect and engineer), Cives Steel Company Corp and Industrial Sprinklers. The project started in 2002 and the construction of the facility started in 2003; the structural work was completed by 2005.

The validation and commissioning of the plant required a further two years to complete. The plant employs around 250 personnel, but this is due to increase to 300 over the next year.

HUMIRA

Humira has now been approved for four major immune system-caused diseases in more than 50 countries worldwide.

The biologic drug is a major success for Abbott, having had sales of over $2bn in 2006.

Sales are expected to break the $3bn mark in 2008 as the drug becomes more widely used.

Abbott has now submitted a new biologics license application (BLA) with the FDA and EMEA for the treatment of chronic plaque psoriasis (April 2007) and for juvenile rheumatoid arthritis (May 2007). EMEA approval for use in the treatment of chronic plaque psoriasis had been granted by December 2007.

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