CONCEPT: core national facility for early-stage biotherapy development

Barry Shortt

Business Development Manager, NIBRT

A state-of-the-art facility fosters collaborative development pathways in advanced therapies, providing research-grade materials to bridge the gap between innovation and clinical application.

Ireland has hads a rich history in pharmaceutical manufacturing since the 1950s. Its manufacturing ecosystem has since evolved, embracing technological advancements in producing small and large-molecule therapies to address various diseases. Today, the Irish bioprocessing industry faces new challenges and opportunities with the expanding pipeline of advanced therapies.

Increasing advanced therapy clinical trials

Global estimates point to 12,500 advanced therapy clinical trials assessing over 80 modalities including approximately 500 cell therapy products. To date, the FDA has approved 27 cell and gene therapies but anticipates 10–20 per year by 2025, in addition to newer technologies such as complex ADCs and CRISPR gene-edited therapies coming through the clinical pipeline.

One of the most significant hurdles in therapy development and novel modalities is translation from academic concepts to clinical trials assessment. Lack of funding, limited access to specialist equipment or knowledge gaps can lead to unfulfilled development pathways. National Institute for Bioprocessing Research and Training (NIBRT), with the Irish Government and Science Foundation Ireland (SFI), identified this developmental hurdle and devised a strategy called CONCEPT to address it.

To date, the FDA has approved 27 cell and gene
therapies but anticipates 10–20 per year by 2025.

Accelerating early-stage advanced therapy development

The CONCEPT facility is in a custom-designed suite of laboratories at NIBRT, located in Dublin. This newly built extension was financed by IDA Ireland to support the next wave of biopharmaceutical investment in advanced biotherapy research and training.

Central to the operation of this facility is state-of-the-art instrumentation funded by SFI. These next-generation instruments drive accelerated workflows and are accessible to academic researchers and those in industry, to rapidly deliver outcomes for the next development phases.

Hope for developers of advanced therapies

Ireland’s pharmaceutical manufacturing legacy adapts to meet the demands of advanced biological therapies. CONCEPT bridges the gap between fundamental ideas and clinical trials. With strategic partnerships and cutting-edge equipment, it accelerates research outcomes, fostering collaboration between academia and industry. Positioned at the forefront of biopharmaceutical innovation, CONCEPT signifies a bold investment in Ireland’s healthcare future, facilitating advancements in advanced therapies.