Irish SFI-funded research centre SSPC has announced a collaboration with five major BioPharma companies that aims to reduce waste, maintain standards and minimise costs in pharmaceutical processes.
The rising need for early diagnosis of chronic diseases, coupled with growing demand for drugs which work better and have fewer side effects, is largely responsible for the growth of the protein A resin market.
Protein A resin is essential for a process called chromatography which is a step in antibody purification during the manufacture of antibody medicines.
Chromatography requires an antibody to bind to a protein A resin. Any impurities present are washed through before the bound antibody is then released in a pure state.
At the moment, protein A resin cannot be reused. If BioPharma companies use it with one antibody, they can’t use it with a different antibody.
The resins are expensive and in short supply. A current global shortage of protein A resin, is slowing product analysis across the sector, thus increasing the cost and slowing the rate at which new antibody medicines can reach the patient.
This project will explore the possibility and feasibility of reusing these resins, making the production of antibody medicines, faster, cheaper and more sustainable.
The project is led by SSPC Principal Investigator Dr Sarah Hudson, Bernal Institute, University of Limerick (UL). Dr Hudson and her team will investigate the multi-product use of a resin in downstream biopharmaceutical production at the Bernal BioLabs.
“This is a unique project that has come from a very open collaboration between the 5 industrial biopharmaceutical partners and UL,” said Dr Hudson.
“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 production of cheaper and better medicines for all with minimal environmental impact.”
Aisling Arthur, SSPC’s Industry Engagement Manager said: “The extensive expertise, research infrastructure and capabilities within the SSPC allows us to deliver innovative solutions to our industry members in both small and large molecule manufacturing and we are very excited to be leading this important partnership for the BioPharmaceutical sector.
“Linking in with the international BioPhorum group, we anticipate that the outputs from this collaboration could challenge current regulatory thinking around the multi-product reuse of resins in specific circumstances.”
SSPC and its partners will determine the feasibility of resin reuse for multiple antibody products and will use the data generated to develop best practice guidelines on resin reuse across the BioPharma sector.
Pfizer (Grange Castle), Eli Lilly (Kinsale), Janssen Sciences Ireland (Ringaskiddy), BMS (Cruiserath Biologics) and MSD Biotech (Dublin) have all joined a partnership with SSPC to tackle this important challenge for the sector.
The project is expected to build confidence that will challenge current regulatory thinking around the multi-product reuse of resins in specific circumstances.
The project team will inform regulatory opinion by disseminating results at conferences with a regulatory audience. Product carryover and cleaning effectiveness will be assessed, as well as mass spectroscopic analytical methods and in-depth characterisation of the resin, including binding efficiencies.
The SSPC project consortium is also collaborating closely with the global BioPhorum Group (BPOG) to further increase the value and impact of this project.