Pfizer’s Worldwide Research & Development (WR&D) division developed the Global Biotherapeutics Technology group at Grange Castlewellan, Ireland, in 2006. The unit was formed as a global leader in protein drug discovery.
The biotechnology campus was originally built at an estimated cost of $1.8bn by Wyeth, which was formerly known as American Home Products (AHP). The facility became part of Pfizer’s assets in October 2009 when it acquired Wyeth.
Location of Pfizer’s Clondalkin biopharmaceutical plant
The multiproduct biopharmaceutical campus is located at the 90-acre Grange Castle International Business Park in Clondalkin, Ireland. It is strategically located as Ireland is a prime location for pharmaceutical investments in Europe.
The facility is part of Pfizer’s speciality biotech operating unit, which also includes Pfizer’s facilities in Andover, Sanford, and Pearl River, US; Havant, UK; Algete, Spain; and Strängnäs, Sweden.
Pfizer’s biotechnology campus details
The Pfizer biotechnology campus focuses on the production of active pharmaceutical ingredients (APIs), solid-dose pharmaceuticals, sterile injectables, biopharmaceuticals, and vaccines.
The site houses various groups involved in the product development process, including the Manufacturing Sciences and Technology Group, the Technical Services Group and the Global Biotherapeutics Technologies Group. More than 1,100 people are employed at the site.
In addition, the facility houses a cutting-edge pilot plant, laboratories, and equipment for the development and manufacturing of a wide range of biological drugs, including proteins and vaccines.
Phases of the biotechnology plant’s expansion
The original facility was designed to meet its current needs and future capabilities. It facilitates the manufacturing of bulk drug substances and fill-finishing biologics, vaccines and antibiotics on one campus.
In April 2007, the development laboratory at the facility was expanded from 2,500m2 to 8,500m², which required an investment of $32m and was fully supported by the Irish Development Agency (IDA).
In 2009, Suite A1 was built to support a clinical programme, and a second syringe line was added to Suite Three in 2010.
Pfizer announced a €145m ($200m) expansion of the facility in September 2011. Works included the construction of Suites Two and Four, adding 4,263m2 of building space.
Suite Three was expanded to manufacture pre-filled syringes for Pfizer drug Prevenar 13. A cell bank storage expansion was also undertaken at the site.
Pfizer announced a €300m ($298m) capital investment in November 2020 to support the expansion of its current production facilities in Grange Castle, Newbridge, and Ringaskiddy.
In May 2021, the company announced another $40m investment to expand the Grange Castle site to produce the Pfizer-BioNTech Covid-19 mRNA vaccine.
Manufacturing and drug development
The drug development unit moves products from the research pipeline to commercial-scale manufacturing. It coordinates and validates technologies and procedures required to take drug substances into full production.
The drug substance facility carries out the beginning and intermediate stages of manufacture for cell culture products, which include media preparation, fermentation and purification.
Products are then packaged as sterile vials. Stages of production include formulation, vial preparation, filling, capping and inspection.
Drugs produced at Pfizer’s facility
The Grange Castle facility produces etanercept, an active ingredient in rheumatoid arthritis drug Enbrel®. It also manufactures the paediatric pneumococcal conjugate vaccine Prevenar®.
The site also produces other leading drugs and vaccines for arthritis, inflammation, cancer, anti-infectives, haemophilia, pain, and stroke.
The Grange Castle facility’s development work began in October 2002. The construction schedule was planned to carry on limited production in the final quarter of 2004 for validation, which in turn allowed the plant to open on schedule in September 2006.
Construction required more than 15,000t of structural steel, 160,000ft of process piping, 2,400 items of equipment, 7,587 engineering drawings, and 1,200 specific validation protocols.
Contractors involved in the project
Project management was overseen by Wyeth Medica Ireland, Wyeth BioPharma and Wyeth Global Engineering.
Project management support was provided by professional services firm Arup, project and programme management consultancy Atkins Faithful & Gould, management consulting firm Bio-Pharmaceutical Consulting, and consulting and financial planning services provider Keating & Associates.
Contractors carrying out work at the site included civil engineering company Roadbridge, engineering contractor Mercury Engineering, electrical and instrumentation engineering solutions provider Suir Engineering, steel fabrication and construction firm Cronin Buckley, construction group SIAC, builder and contractor J Sisk and Son, and GF May.
Other contractors include equipment supplier Fisher, HA O’Neill company Jones Engineering Group, roofing and waterproofing solutions provider GFM System, flooring solutions provider Crean Mosaics, design and build solutions provider Bruns Pak, cladding solutions supplier Prince Cladding, and laboratory construction company PJ Hegarty,
Equipment for the fit-out of the facility was provided by BOC Edwards, medical technology company Bosch, separation and fluid handling solutions provider Alfa Laval, membrane supplier Millipore, medical equipment company Steris, purification solutions provider Aqua Chem, energy management solutions provider Schneider Electric subsidiary Schneider Electric Ireland, and wastewater treatment systems provider Veolia Water (formerly Vivendi Water Systems).
Zenith Technology was responsible for the validation of all automated systems.