Centocor Biopharmaceutical Manufacturing Facility, Baranhely, Ringaskiddy, Republic of Ireland

Centocor Inc, a subsidiary of Johnson & Johnson, announced in July 2004 the investment of €180m in the construction of a new state-of-the-art biopharmaceutical manufacturing facility in Barnahely, Ringaskiddy, Republic of Ireland. The design was completed by November 2004 and ground breaking was in July 2005.

The new facility was constructed in Ireland to take advantage of generous tax advantages and incentive grants offered by the Irish Development Agency (IDA) and the Irish government, subject to European Union (EU) approval. Centocor also chose Ireland because of its location near to the company's production base in Leiden in Holland.

PROJECT

The facility was constructed on an IDA-owned, 100-acre brownfield site in Barnahely. The plant consists of a 10,000m² production building along with a central utilities building, a laboratory and administration block, waste water treatment plant and warehousing/storage. All of the buildings are linked along a central spine-link corridor. The four main buildings comprises a total floor space of approximately 24,391m².

The facility now forms the strategic manufacturing centre of a new global supply chain for the company for many of their existing and new pipeline recombinant mammalian cell fermentation and monoclonal antibody products. The new manufacturing unit at Barnahely will produce products for the detection and treatment of many human diseases on a commercial scale but also is used to produce smaller quantities of drug material for clinical trials.

Construction of the manufacturing plant was complete by September mid-2007 and, following commissioning of equipment and validation, should be in full production by 2008. The plant is due to employ over 350 new personnel gradually over the next five years, 60% of whom will be pharmacists, chemists, process engineers and biopharmaceutical specialists.

CENTOCOR CONTRACTORS AND CONSTRUCTION

McCarthy Lynch designed the facility. The engineer, procurement and supply (EPS) contractor and construction management consultant for the project was SISK Pharma Division. The building was constructed using an advanced MUSKITA Mu-8XX curtain wall system integrated with Kingspan cladding which gives the advantage of superior thermal breaks to minimise cooling and heating costs throughout the year, as the maintenance of a constant controlled internal environment in a biopharmaceutical facility is of the utmost importance. Classic Building Solutions Ltd, of County Cork, carried out the external building work.

The facility includes bioreactors of commercial scale and clinical scale along with the associated class 100,000 cleanroom, media preparation, refolding and downstream processing and separation facilities (filtration and chromatography). The new plant also incorporates a process development section, where fermentation processes can be conceived and optimised to give the best possible yields of product, in addition to state-of-the-art plant and process automation to make it one of the most modern in Europe.

Low temperature refrigerated warehousing facilities are available for both products and ingredients as well as a small-scale fill and finish facility for packaging clinical quantities of products. Fill and finish will be mainly carried out in Holland.

CENTOCOR REMICADE

Remicade is a monoclonal antibody product that will be produced at the new facility. The drug is used to treat autoimmune diseases such as rheumatoid arthritis (RA), Crohn's disease and psoriasis that are caused by over-production of tumour necrosis factor α (TNF-α). The drug is highly successful, achieving sales in excess of $1.3bn in 2003 (being the first biotechnology blockbuster to do this).

Remicade was first approved in 1998 for RA and Crohn's disease (it is the only FDA approved product for Crohn's disease) but the company hopes to extend the usefulness of the drug by continuing clinical trials into other autoimmune diseases such as ulcerative colitis, psoriasis, ankylosing spondylitis, lupus erythrematosus and psoriatic arthritis; the drug is often referred to by Centocor as a 'pipeline in a product' because of its potential new uses.

The success of this drug, and others in the company pipeline such as Reopro (a heart medication), has highlighted the need for the company to obtain extra production capacity, particularly at a time when rival drugs such as Enbrel and Humira are about to come to market. Ron Prachar of Centocor commented: "The company sees the need to start thinking about capacity five to six years in advance…anticipating the demand for this product (remicade)".