Brendan McGrath

Ireland Site Head and VP of Manufacturing, WuXi Biologics

Dr Eimear McCarron

Senior Director of Quality, WuXi Biologics

Gene Russell

Senior Director of Engineering, WuXi Biologics

A major biologics manufacturing plant in Ireland combining state-of-the-art facilities and environmentally conscious practices is playing a pivotal role in the global biopharma supply chain.

The pharmaceutical sector has emerged as a critical component of the Irish economy in recent years. Supported by leading global manufacturers, it provides employment opportunities for local talent and fosters a supply chain spanning production, technology and administrative support. Additionally, it strengthens Ireland’s position as a global hub for life sciences and biopharma innovation. One of the newer companies in Ireland’s pharma sector is WuXi Biologics, which began operations at its commercial-scale biologics manufacturing hub at Dundalk in 2022.

Shortening supply chains

From seeing some 1,800 construction personnel build the plant, it now employs 770 full-time equivalent personnel in an operation that works closely with the world’s biggest pharma companies. The arrival of WuXi Biologics also highlights the importance of Ireland’s position geographically and economically in the global drug arena, shortening supply chains to Europe and the United States sustainably.

Brendan McGrath, Ireland Site Head and VP of Manufacturing, points to the site’s role in supporting global biopharmaceutical innovation and ensuring a reliable supply. “We established the facility at the request of clients who were looking for geographical closeness in relation to reducing pressure on supply chains,” he explains.

That was graphically illustrated when the Covid-19 pandemic gripped the planet and supply chains were severely disrupted when a container shipped blocked the Suez Canal for several weeks in 2021. “That showed the importance of reducing reliance on long supply chains and trying to bring partners closer to point of use,” adds McGrath. “An added benefit is the positive impact on the environment by not having to ship materials and products around the world.”

Single-use technology

WuXi Biologics is a global contract research, development and manufacturing organisation (CRDMO). Its Ireland greenfield site specialises in large-scale, single-use bioreactor facilities for commercial biologics manufacturing. It provides end-to-end solutions to support the discovery, development and production of biologics. With a production capacity of 54,000 litres, the Dundalk facility’s capabilities include its 48,000L fed-batch and 6,000L perfusion suites.

“Single-use technology in our bioreactors allows us to provide a more flexible manufacturing opportunity, particularly where there is a product that is going to be new to market,” says McGrath. The single-use capability — an alternative to traditional stainless-steel systems used in bioprocessing — offers significant operational efficiencies, including better cost of goods (COGS).

It also reduces resource consumption, such as water and energy, making it a more sustainable and economical option for bringing a product from discovery to commercialisation. In that way, the site contributes to the production of breakthrough therapies, especially in addressing global health challenges for rare diseases that may have an unmet therapy with the production of so-called orphan drugs made in smaller amounts.

Single-use technology in our bioreactors
allows us to provide a more flexible
manufacturing opportunity.

Quality standards

Dr Eimear McCarron, Senior Director of Quality, underlines how quality is maintained within the processes both at development and commercial production. The company’s quality compliance record is rooted in the strong quality culture at the Dundalk facility, which has consistently demonstrated control through effective execution.

Blending the synergies of scientific knowledge with regulated quality policies and engineering practices has resulted in the plant receiving the prestigious 2023 ISPE Facility of the Year Award for Operations shortly after achieving initial GMP (Good Manufacturing Practice) certification in 2022 from the Health Products Regulatory Authority (HPRA) in Ireland.

The site’s Quality Risk Management programme led by Dr McCarron points out that the site’s Quality by Design (QbD) approach allows data to flow smoothly, supporting the foundations for a strong end-to-end model for product release. “A strong compliance culture has led to the successful commercialisation of the site’s ability to manufacture clinical and commercial drug substance of small and large molecule and biologic treatments for multiple clients serving the needs of patients,” she adds. “The Dundalk operation has a clear approach to continuous improvement in operational efficiency and quality control, leveraging the most current technology and innovation to minimise risks.”

Supporting businesses and talent

From construction to becoming operational, the plant has supported an ecosystem of local businesses, suppliers and research collaborations. McGrath says the world’s top 10 pharma companies have a presence in Ireland, and the support of that ecosystem of construction, equipment, technical expertise and supply chain vendors has been pivotal.

An additional contribution has been in nurturing local talent through partnerships with Irish universities and training programmes aimed at building a skilled workforce. “To grow our workforce, we have a mix of employees: attracting existing employees from other companies that may have many years of experience; attracting graduates to a state-of-the-art facility and also some employees new to the sector and want to join our industry,” says McGrath.

That has seen close liaison with Dundalk Institute of Technology (DkIT) and liaison with universities and students on biopharma and science courses, attending college fairs, holding on-site recruitment days and using technical services such as those provided by the National Institute for Bioprocessing Research and Training (NIBRT).

Attractive environment

The company has a STEM strategy and works with schools and colleges to help potential recruits understand the roles of scientists, microbiologists, manufacturing technologists and data analysts to link the pathway from classroom subjects to a successful career in the biopharma sector. That additionally includes being industry partners of the Virtual Labs Project, Women in STEM initiative and core members of leading industry biopharma bodies.

There are advancement opportunities within the company, which has sites in the United States, Germany, China and Singapore, providing services to 600 partners globally, including the top 20 pharmaceutical companies. Ireland’s established reputation as a life sciences and biopharma innovation hub is further enhanced by the presence of companies such as WuXi Biologics, particularly as the first large-scale CRDMO in the country.

“It is a very attractive environment for people who are seeking new opportunities in a dynamic and fast-paced environment, the types of technology platforms and products are cutting edge and represent the industry’s future. It is a different pace to big pharma and takes different skills and mindsets,” says McGrath. With 22 different nationalities in the workforce, the aim over the next decade is to become a ‘partner of choice’ for the major pharmaceutical players and see additional products come to the site, potentially leading to expansion. “We want to become a trusted partner and have an impact on patients’ lives in a positive way through the products we manufacture,” adds McGrath.