AMECRYS Collaboration Reaches Important Project Milestone
01 Nov 2018
The Centre for Process Innovation’s (CPI) contribution with FUJIFILM Diosynth Biotechnologies to the AMECRYS collaboration has hit an important milestone.
The project, known fully as Revolutionizing Downstream Processing of Monoclonal Antibodies by Continuous Template-Assisted Membrane Crystallisation, has moved forward with the successful technology transfer of the expression and purification of model mAbs from FUJIFILM to CPI.
AMECRYS is a research project funded entirely by the European Commission under the Horizon 2020 programme, in the framework of Future and Emerging Technologies actions (FET-OPEN), supporting early-stages of science and technology research and innovation around new ideas toward radically new future technologies.
The consortium is made up of six academic institutions and three industrial partners from the UK, Italy, France and Belgium.
![As part of the AMECRYS project, a prototype crystalliser will be installed at CPI’s biologics facility, based in Darlington As part of the AMECRYS project, a prototype crystalliser will be installed at CPI’s biologics facility, based in Darlington](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-centre-exterior.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559219146&s=351380477d0548908ee815f864bb504f 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-centre-exterior.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559219146&s=1d58da088242c72ced33c63c897d4df6 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-centre-exterior.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1559219146&s=669ef221bc8522edc2e0b0fa085df2d0 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-centre-exterior.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559219146&s=fe21841c52b5256f6c11e25d39d88a4b 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-centre-exterior.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559219146&s=fbb8e54fae746526bee0ae23aafb4d80 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-centre-exterior.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559219146&s=494cb104c7d6904b02e74a692ce67a6f 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-centre-exterior.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559219146&s=00f55257d4b6cc5ea2c92d7a39a6b064 960w)
The aim of the ongoing project, which is on track for completion in October 2020, is to unlock the industrial application of protein crystallisation 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 FUJIFILM which represent important therapeutic formats, such as anti-cancer antibody molecules.
DSP is a critical step for removing impurities and contaminants during the manufacture of biopharmaceutical proteins, due to the high levels of purification that these drugs require.
The current chromatography-based DSP platform for mAbs accounts for approximately 60 per cent 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 life-changing therapeutics to healthcare providers.
![The prototype crystalliser, due to be installed at CPI’s Darlington biologics facility, will complement existing cutting-edge equipment, shown above The prototype crystalliser, due to be installed at CPI’s Darlington biologics facility, will complement existing cutting-edge equipment, shown above](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-reactor-ii.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559218033&s=f2f974b50a6b3be2c33f1e024bd031c3 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-reactor-ii.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559218033&s=5a484e70b893ab9b00122d661d590fc5 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-reactor-ii.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1559218033&s=bd485362be8b512e311477c1eeece645 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-reactor-ii.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559218033&s=f89cafc9d61bbe0f80c0bae03303bcce 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-reactor-ii.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559218033&s=35979fc49dbc6908371eac1c4d9511a1 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-reactor-ii.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559218033&s=90393d743323305e862e0da4b0dad950 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biologics-reactor-ii.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559218033&s=2432fd0e16008ad9acbe3822d82e0e67 960w)
The technologies and theory behind the development of template-assisted crystallisation of FUJIFILM’s model 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 crystalliser is installed in CPI’s biologics facilities, in Darlington.
FUJIFILM will continue to provide industry guidance and steer throughout the collaboration from the point-of-view of a global leader in contract biopharmaceutical manufacturing.
“CPI is extremely pleased to be collaborating with FUJIFILM Diosynth Biotechnologies in this ambitious project, which is both yielding positive results and meeting programme milestones.
“As a result, we are moving closer to achieving the collaboration’s aims of developing a novel downstream processing approach that can be applied to routine biopharmaceutical manufacturing.
“This crystallisation-based approach aims to deliver significant improvements through simplifying downstream process operations and reduction in manufacturing costs while maintaining product quality,” said Dr John Liddell, Chief Technologist, CPI.
“Exploring new avenues to bring manufacturing efficiencies, particularly in DSP, is very important for the biopharmaceutical industry. As an organization we are excited to be a contributor in this project,” said Dr Andy Topping, Chief Scientific Officer, FUJIFILM Diosynth Biotechnologies.
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