Over the past several years, biopharmaceuticals have taken their place among the promising therapies approved for human use. Between 2000 and 2004, for example, regulators in the US and Europe approved 75 biopharmaceuticals, including hormones, therapeutic enzymes, vaccines, antibodies, and other therapeutics. The growing importance of biotherapeutics is further evidenced by the market's estimated size: $40 billion and still growing.1
THE NEED FOR A SPECIALIZED FACILITY
Among the leading life sciences companies that have announced intentions to stake out a position in biologics is Pfizer, which is investing $237 million in a monoclonal antibody (MAb) process development and clinical-scale pilot production plant in Shanbally, Ireland, adjacent to its existing facility in Ringaskiddy. Becoming a top-tier provider of biotherapeutics is one of Pfizer's priorities.
Currently, Pfizer ranks 19th in the world in biotherapeutics but the company has announced its intentions to be among the top five by 2015. Central to Pfizer's achieving this leadership position is the recent creation of a new research and development (R&D) division, the Biotherapeutics and Bioinnovation Center, which will advance leading edge biologic technologies and new biotherapeutics into Pfizer's biotherapeutics pipeline and product portfolio. With five biological-based products on the market and a strong, growing biotherapeutics-based pipeline, adequate capacity and capability to manufacture the new compounds will be critically important to the company's growth strategy.
The MAb pilot-plant site at Shanbally, Ireland, before any construction activity (circa 1969). The tree still blossoms there every year.
Designing and building a facility for the production of MAb drug substance is a major undertaking. Not only is the investment substantial, but also the various elements of facility design must be carefully tailored to accommodate processes that may still be developing. Pfizer's Shanbally project offers an excellent illustration of the complex facility design challenges and requirements dictated by the flexibility, speed, and economic value now required by a competitive business environment.
FROM COW PASTURE TO MONOCLONAL ANTIBODIES
Under construction on a 30-acre site adjacent to the Ringaskiddy facility, and on target for completion in late 2009, Shanbally sits 10 miles from the city of Cork in what used to be a cow pasture. Pfizer chose Ireland as the site for the facility because of the favorable business climate, accessibility of an experienced biotechnology talent pool, and close proximity to the company's drug product plant in Dublin, which formulates products produced in mammalian cell culture. The adjacent Ringaskiddy plant was one of the first pharmaceutical plants established in Ireland, initially making citric acid in the 1970s, and shortly afterwards adding an active pharmaceutical ingredient (API) manufacturing facility. Today, it has expanded both its API and drug product presence in Ireland.
Aerial view of the site under construction, from the first pour of the Pfizer small-scale facility in October 2007 to the ongoing progress of steel erection of the main production area and laboratory administration block in February 2008.
The new site in Shanbally will provide MAb drug substance for Phase 2b and Phase 3 clinical studies and perform process validation studies, drug substance and drug product release testing, and stability program testing. Shanbally will play a pivotal role for Pfizer's network in applying MAb platform technologies and producing small-volume commercial supplies for potential therapies in oncology, chronic pain, diabetes, and autoimmune diseases.