From its roots in small molecule manufacturing, Ireland has evolved into a global hub for biologics and advanced therapies, home to nine of the world’s top 10 pharmaceutical companies and the EU’s second‑largest exporter of pharmaceuticals.
The country has proven to be a gateway to EU, UK, and US markets, supported by operational, financial, and geographic advantages. Over the last decade, the biopharma sector has attracted more than €15 billion ($17.4 billion) in foreign direct investment and now employs over 50,000 people across small molecule and biologics facilities.
“Manufacturing has come to Ireland for a number of reasons. We have a competitive business and tax environment, but more importantly, a strong track record of delivery, access to skilled people, and the engineering and design capability to build manufacturing capacity quickly,” Rory Mullen, Head of BioPharma at IDA Ireland, the government’s investment promotion agency, told DDN. “With a limited window of patent protection, companies need certainty — and that includes being able to train their workforce before a plant even comes online.”
Now, Ireland is turning its attention to cell and gene therapies. These cutting-edge treatments, which include CAR T therapies, viral vector-based medicines, and oligonucleotide therapies, are transforming the treatment landscape for previously untreatable and rare diseases. The promise of advanced therapies has brought new opportunities, but also new challenges. This is particularly true for manufacturing, where complexity, regulatory scrutiny, and specialized workforce requirements can create bottlenecks.
Tackling the talent bottleneck
In many facilities, bringing someone from the front door to the factory floor can take as long as 18 months before they’re fully operational. Our focus is on significantly shortening that timeline.
—Darrin Morrissey, NIBRT
One of the biggest challenges facing advanced therapy manufacturing is workforce readiness. Manufacturing biologics and cell-based therapies takes place in highly regulated Good Manufacturing Practice (GMP) environments where employees must be trained not only in science, but also in complex operational procedures. “In many facilities, bringing someone from the front door to the factory floor can take as long as 18 months before they’re fully operational. Our focus is on significantly shortening that timeline,” said Darrin Morrissey, CEO of the National Institute for Bioprocessing Research and Training (NIBRT).
NIBRT was established nearly two decades ago with government backing to address exactly this problem. The institute operates a simulated GMP manufacturing environment equipped with the same equipment used in commercial biologics facilities, allowing employees to train in realistic production scenarios before stepping into real manufacturing plants.
Trainees work through the entire biologics process, from cell inoculation to fill-finish, including responding to simulated errors or process deviations, allowing them to develop operational experience in a controlled setting. “If you have the right trainers, the right equipment, and the right curriculum, you can teach not just how to perform a process, but how to respond when something goes wrong,” Morrissey said.
“Our training programs are fully customized to each company’s needs. For example, we often train staff on monoclonal antibody manufacturing using CHO cells, which is our bread and butter. But we also provide training in viral vector manufacturing, plasma processing, mRNA production, and cell therapies. In every case, we adapt our existing curriculum to match the company’s specific requirements, providing tailored solutions that can be applied immediately.”
NIBRT isn’t just training the GMP workforce — they’re also teaching regulators how to inspect effectively, working closely with manufacturing companies to understand their needs, and collaborating with hardware suppliers who provide the very equipment used in training. On top of that, they maintain strong academic partnerships, driving applied research to continually improve biomanufacturing processes.
In 2025, NIBRT taught more than 4,800 trainees, supporting biopharma manufacturing operations across Ireland and internationally. The institute has also expanded its reach through the NIBRT Global Partners Programme, supporting licensed training facilities in eight locations worldwide, and through the launch of NIBRT Global Qualifications (NGQs), which ensure standardized, world-class training globally.
Manufacturing complexity continues to rise
Companies are increasingly developing therapies involving viral vectors, oligonucleotides, antibody-drug conjugates, and cell-based therapies such as CAR T. Each modality introduces new manufacturing challenges, from product instability to contamination risks and process variability.
“Unlike traditional manufacturing, where the process is relatively stable, and efficiencies build over time, biologics involve highly complex processes with variability, instability, and potential contamination,” said Morrissey. “If you’re just talking about engineering a CHO cell to produce a monoclonal antibody, that’s, in many respects, yesterday’s news. What’s truly remarkable now is the breadth, complexity, and diversity of the biologics pipeline coming through. The challenge isn’t just individual steps, but managing capacity across the entire system to handle this complexity.”
At the same time, geopolitical pressures are prompting companies to regionalize manufacturing, ensuring resilience in Europe, the US, and Asia. “This is particularly challenging for smaller companies, which traditionally only had one or two manufacturing sites but are now moving toward more global supply,” said Mullen. “Being in Ireland offers significant advantages: as part of the EU and the Common Travel Area with the UK, we have access to both labor markets and are strategically located between Boston and Berlin. Many global companies, from Wuxi to SK Biotech, Takeda, and Astellas, have chosen Ireland for biologics and small-molecule manufacturing, making it a neutral hub to supply products worldwide.”
It’s also important to help companies continuously update their operations and adapt to changing circumstances. For example, many pharmaceutical sites are facing the end of high-value patents in the coming years. “As those products lose exclusivity, the sites are adapting to produce smaller-volume, more diverse products, including Phase 3 clinical supplies. This ‘de-risks’ the sites, ensuring they remain active and flexible.” To support this, IDA Ireland and NIBRT offer incentives across innovation, sustainability, and workforce development.
Building a bridge between academia and industry
A defining feature of Ireland’s approach is the deliberate integration of academic research with manufacturing. NIBRT hosts around 120 staff members, including roughly 80 researchers who hold joint appointments with universities across Ireland and the UK. These collaborations allow academic researchers to focus directly on industry challenges related to manufacturing.
“Our mission is twofold: workforce development for GMP biologics manufacturing and applied research focused on improving biomanufacturing. Ultimately, it’s about tackling the complexity of producing biological medicines, from monoclonals to advanced therapies,” said Morrissey.
This approach helps translate early scientific insights into practical solutions for biomanufacturing. “Increasingly, our research is focusing on advanced, next-generation modalities, because that’s where the biggest challenges lie,” Morrisey explained.
For example, NIBRT is running collaborative cell therapy projects with several key investors, supported by both significant state and industry funding. Sakis Mantalaris, a joint appointee with Trinity College Dublin and the newest member of the NIBRT Principal Investigator team, is a key figure in this fundamental research. He leads work on metabolomic profiling of cell-based therapies, examining how cellular makeup affects product quality for patients and influences the manufacturing process.
Other notable examples include Mark Smales, jointly appointed with the University of Kent, and Jonathon Bones, a joint appointee with University College Dublin. Smales has spent two decades pushing the boundaries of biomanufacturing, turning fundamental insights into tangible advances across recombinant proteins, gene and RNA therapies, synthetic biology, extracellular vesicles, and diagnostics. Bones, meanwhile, is a world leader in advanced analytics for biomanufacturing. Partnering with Thermo Fisher, he is harnessing mass spectrometry to build predictive algorithms that optimize both upstream and downstream processes for mRNA, siRNA, and other cutting-edge therapies.
This research is particularly relevant because, unlike monoclonal antibodies — which have been standardized over decades with stable, platformed processes — cell therapies are still highly bespoke. Each process is different, with no universal standard. “Cell therapy today is almost like a cottage industry,” Morrissey said. “Everyone has their own recipe.”
By connecting industry, training, and academia so closely, Ireland is not only producing a skilled workforce but also driving innovative solutions to scale complex therapies.
Lessons for the global biopharma industry
Building advanced therapy manufacturing capacity requires far more than constructing new facilities, Mullen noted. It requires a coordinated network that connects academic research, engineering expertise, workforce training, and regulatory oversight. “Standing up that kind of ecosystem quickly is extremely difficult,” he said.
Standing up that kind of ecosystem quickly is extremely difficult.
—Rory Mullen, IDA Ireland
For emerging therapy modalities such as cell and gene therapy, the success of manufacturing strategies may ultimately depend not just on technological innovation, but on whether countries can develop the talent pipelines and collaborative infrastructure needed to support them.
