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 was previously manufactured at the Worcester, Massachusetts facility but production will now centre on the Puerto Rico operation. This will leave Worcester acting in a supporting role and also in the research and development of new compounds such as ABT-874, an investigational anti-interleukin/anti-interleukin 23 biologic for autoimmune diseases such as Crohn's disease and psoriasis.

Humira is used to treat a variety of conditions including psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis (JIA) in children, chronic plaque psoriasis, rheumatoid arthritis and as a self-administered treatment for severe Crohn's disease. It was approved in Europe in April 2007.

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 (£336m) and has been designed for large-scale production of biologic compounds. The new plant has 12,000l bioreactor vessels for biologic production and also over eighty tanks and vessels for the culture and processing of cells in production.

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 increased to 300 during 2007–2008..

Humira

Humira has now been approved for six 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 $4.4bn mark by the end of 2008 as the drug becomes more widely adopted. Abbott third-quarter results released in October 2008 showed an increase in profits of 51%, led by strong Humira sales.

Abbott 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 and the FDA followed suit by granting a similar approval in January 2008. FDA approval for use in treating juvenile rheumatoid arthritis was granted in February 2008.