Biologics offer promising treatment options for disease areas with unmet clinical needs, and now represent seven of the top ten grossing drugs globally. As part of the Digital Integrated and Intelligent Continuous (bio)Manufacturing (DIICbM) project, CPI and its partners will develop new tools to accelerate workflows and integrate process analytical technology into CPI’s existing automated platform for continuous downstream bioprocessing.
David Lovett, managing director at Perceptive Engineering, said, “By using advances in at-line process analytical technology, the DIICbM project will help to optimize end-to-end manufacturing processes at CPI’s National Biologics Manufacturing Center. With strategic guidance from world-leading partner FujiFilm Diosynth Biotechnologies, we are hugely excited by this project.”
Utilizing Perceptive Engineering’s PharmaMV software, the partners will collect and analyze data from CPI’s automated platform to build a model that can identify and predict the degradation and failure of purification resins. Additional data to refine the model will be provided by FujiFilm Diosynth Biotechnologies. The resins used in the manufacture of biologics are extremely expensive, and failure not only means they must be replaced, but also leads to batches of drugs that do not meet quality standards. The model being developed will enable a much greater understanding of resin failure, and the partners are working to integrate it into CPI’s automated platform to provide real-time insights. This will enable early interventions, while promoting the development of better processes that avoid resin failure altogether.
“Fully optimizing and automating continuous downstream processes is a vital part of streamlining biologics manufacture. Our facilities have the ideal combination of expertise and instrumentation to test and prove the innovative new technology that can achieve this,” commented Lucy Foley, Biologics business unit director at CPI.
CPI was instrumental in identifying the funding streams available for the project and writing the initial proposal. Once a working model is developed, CPI will demonstrate proof-of-concept at its National Biologics Manufacturing Center in Darlington, UK, and it will also investigate the model’s transferability to other platforms.