The Research Ireland Centre for Pharmaceuticals (SSPC) has partnered with Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) to develop technologies to address R&D and manufacturing challenges facing the sector.
The manufacturability of drug candidates coming out of the research lab will be a major focus of the new collaboration, according to Damien Thompson, SSPC scientific director.
“The biopharma sector faces the challenge of enhancing R&D processes with a view to increased manufacturing efficiencies and product quality.”
“Additionally, the biopharma development pipeline is comprised of a diverse array of therapeutic modalities, ranging from recombinant proteins and peptides to viral gene and cellular therapies. By working collectively, SSPC and NIBRT aim to significantly progress the state of the art in biopharmaceutical development, scale-up, and manufacturing,” he told GEN.
Process development will be another focus. SSPC and NIBRT will use hybrid mechanistic-machine learning models to investigate current processing bottlenecks such as variability in biotherapeutic productivity.
“This approach will be applied across the production process at multiple scales of operation from raw materials through upstream cell culture, downstream separations, and finally formulation of drug product,” Thompson said.
Last year, NIBRT expanded its pilot-scale GMP-simulated facility, increasing the building’s capacity to 8,000 m². SSPC and NIBRT will use the lab to develop processes for advanced therapies, including cell and gene therapies, Thompson said.
Industrial applications
The ultimate aim of the collaboration is to develop technologies and strategies industry can use to resolve real-world manufacturing challenges, Thompson said.
“The expertise, tools, and facilities shared across the centers ensure that the processes we explore together are representative of emerging biopharmaceutical production processes, allowing the modeling and analytics frameworks to be applied directly in industry to internal processes and datasets.
“In addition, this approach allows insights derived and emergent findings across multiple operations to be used and further co-developed with industry,” he said.
Partnerships
The University of Limerick-based SSPC is the largest biopharmaceutical research collaboration in Ireland with a team of 79 academic investigators, over 50 industrial partners, and 60 global academic collaborations.
Dublin-based NIBRT focuses on manufacturing. It provides training and research support across all parts of the biological manufacturing process, from upstream cell engineering though to the final stages of product fill and finish.
The new partnership builds on earlier collaborations like the Spokes Project that saw SSPC and NIBRT work with Allergan, Biomarin, Eli Lilly Janssen, MSD, Pfizer, and Sanofi on the control of extractables and leachables from single-use technologies.
