The continuing importance to global pharma giant MSD of its Ballydine, Co Tipperary, facility has been underlined by the recent announcement of a €40 million investment in the site. This is on top of a €35 million spend at the plant over the past three years. This year’s investment includes the installation of a new spray-drying facility, a technology used in a number of new products to increase their solubility and improve how the medicines are absorbed by patients.
Established in the mid-1970s, MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines and exports to more than 30 countries. Over that 40-year period the facility has grown and evolved from a pure manufacturing site to encompass a range of value adding research, development and innovation activities.
“We started out as a manufacturing plant for active pharmaceutical ingredients [API] back in 1976,” Ger Carmody, site lead at MSD Ballydine. “We continue to manufacture a number of products for supply worldwide and that has been our mandate for many years. But during the middle of the last decade, around 2005, our mandate changed somewhat. We continued with API manufacture but were also designated as a commercialisation site.”
This saw the Ballydine site becoming involved in the development of new products in the MSD pipeline. “We are involved small molecule – chemistry based – pharmaceuticals,” Carmody adds. “We were designated as one of just two commercialisation sites in this area globally.”
Formulation
Puerto Rico was the other one and it was responsible for formulation commercialisation work. Ballydine's mandate expanded still further in 2010 when it moved into the formulation area as well.
“We opened up the formulation facility in 2010,” he says. “That saw us move beyond active pharmaceutical ingredients for the first time. That was a big change. We have been building that up ever since. We balance our work in supplying products with the development of the next set of products. We have been working on things like the next generation of HIV and hepatitis C drugs as well as other important products.”
Commercialisation is a key component in the overall research and development process, Carmody adds. “The primary research happens in MSD’s research centres. At a certain point in time there is a need to scale up production either for clinical trials or global manufacturing. Manufacturing methods have to be tested for quality, safety, and the ability to scale up. We have to ensure that new products are suitable for high volume production. Also, when we file for product approval we get questions back from regulatory authorities in different jurisdictions. We get involved in providing the answers to those questions. It’s about finding the best way to manufacture a product at scale. This requires a deep understanding of the manufacturing process. We also develop robust processes to protect the product during manufacturing.”
Global network
Referring to the latest investment, Carmody says it reflects the growing importance of MSD Ireland’s operations to the company’s global network. “It is a fitting way to mark 40 years of MSD in Ballydine. As a leading healthcare company, our growth and development has been built on continually embracing new ways of working, as well as the latest cutting-edge technologies. Our highly-skilled local workforce is now leading the way in the development of new medicines, including MSD’s new treatment for hepatitis C, which is being manufactured in Tipperary for patients around the world.”
It’s not all about scale, however. “It’s really important that we keep up to date for new products coming through,” he adds. “The spray-drying capability is an example of this. Some new products require this and we haven’t had this before now. Also, some products require smaller scale production and we are investing in the technology for this as well.”
He explains that the new treatments and the changing nature of drugs are having an impact on production requirements. “Hepatitis C products, for example, are now aimed at curing the condition rather than long-term treatment so less drugs are required. Other drugs are more potent requiring less volume. And then there are niche products aimed at smaller patient populations. These are the trends which are leading to smaller production volumes. The plant was initially built for high-volume products like cholesterol lowering and asthma medicines but we have evolved over the years to stay up to date with the latest requirements.”
