The new project aims to address a global shortage of important medicine production components and develop more sustainable industry practices.
SSPC, the Science Foundation Ireland (SFI) research centre for pharmaceuticals, has announced a major partnership agreement with five biopharma companies.
It will work alongside Pfizer, Janssen, Eli Lilly, BMS and MSD to try to address a global shortage of protein A resin. The resin is a necessary ingredient for chromatography procedures in the production of antibody medicines.
During chromatography, which is part of the antibody purification process, antibodies bind to protein A resin while impurities are washed away. The antibodies are then released in a purified state.
Currently, protein A resin is single-use, and SSPC described it as “expensive and in short supply”. The shortage is increasing the cost and slowing the rate at which new antibody medicines can reach patients, the research centre added.
The supply crunch is attributed to the rising need for early diagnosis of chronic diseases and increasing demand for effective drugs.
The new project will investigate the feasibility of resin reuse, which SSPC hopes will make antibody medicine production “faster, cheaper and more sustainable”. The investigation will be led by SSPC principal investigator Dr Sarah Hudson, a researcher in the Bernal Institute at the University of Limerick (UL).
“This is a unique project that has come from a very open collaboration between the five industrial biopharmaceutical partners and UL,” Hudson said.
“SSPC is delighted to be able to provide a platform for the different companies to engage and interact with each other with a common end goal that is very much aligned with our own strategic research goals at SSPC and the Bernal Institute, where the work will be carried out.
The project will, as the investigation proceeds, develop best-practice guidelines on the reuse of resins for use across the biopharma industry, which the research centre said will “challenge current regulatory thinking around the multi-product reuse of resins”.
The team plans to disseminate the results at regulatory conferences to inform future policymaking in this area.
SSPC is based out of UL and last year received an SFI grant to build a pharmaceutical manufacturing centre at the university to boost industry collaboration.