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Fujifilm Diosynth Biotechnologies and the Centre for Process Innovation (CPI) are collaborating to complete the technology transfer of the expression and purification of model monoclonal antibodies (mAbs) as part of AMECRYS, a research project funded by the European Commission.
Fujifilm Diosynth Biotechnologies (FDB) announced on Nov. 1, 2018 that its collaboration with United Kingdom-based innovation center, the Centre for Process Innovation (CPI), for the project AMECRYS: Revolutionizing Downstream Processing of Monoclonal Antibodies by Continuous Template-Assisted Membrane Crystallisation has hit an important milestone with the successful technology transfer of the expression and purification of model monoclonal antibodies (mAbs) from FDB to CPI.
AMECRYS is a research project funded by the European Commission under the Horizon 2020 program in the framework of Future and Emerging Technologies actions (FET-OPEN), which supports early-stages of science and technology research and innovation around new ideas toward new future technologies. The consortium is made up of six academic institutions and three industrial partners from the UK, Italy, France, and Belgium.
According to FDB, the aim of the ongoing project, which is on track for completion in October 2020, is to unlock the industrial application of protein crystallization in biopharmaceuticals by developing an innovative, continuous downstream process (DSP) for mAb purification based around a template-assisted membrane crystallizer, which could lead to the replacement of the expensive and cumbersome conventional multi-step batch chromatography-based platform. The new process will be tested on in-house molecules employed by FDB which represent therapeutic formats such as anti-cancer antibody molecules.
DSP is a critical step for removing impurities and contaminants during the manufacture of biopharmaceutical proteins because of the high levels of purification that these drugs require. The current chromatography-based DSP platform for mAbs accounts for approximately 60% of the financial burden of biopharmaceuticals manufacturing and thus requires new technology in order to reduce these production costs, and ultimately reduce the cost of these therapeutics to healthcare providers, FDB reports.
The technologies and theory behind the development of template-assisted crystallization of FDB’s mAbs has been developed in conjunction with The National Research Council of Italy (CNR), The French National Center for Scientific Research (CNRS), Imperial College London, The University of Calabria, The Free University of Brussels, and The University of Strathclyde. The membranes themselves will be produced by the Italian filter technology company GVS, before the prototype crystallizer is installed in CPI’s facilities at the National Biologics Manufacturing Centre in Darlington, UK. FDB states that it will continue to provide industry guidance and steer throughout the collaboration from the point-of-view of a contract biopharmaceutical manufacturer.