Fujifilm Announces That Amecrys Collaboration Reaches Project Milestone To Develop New Technologies To Improve Downstream Processing Of Monoclonal Antibodies

FUJIFILM Diosynth Biotechnologies (FDB) recently announced that its contribution with the Centre for Process Innovation (CPI) to the collaboration project entitled ‘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 mAbs from FDB 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 the 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 United Kingdom, Italy, France and Belgium.

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 FDB 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% 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 technologies and theory behind the development of template-assisted crystallisation of FDB’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 facilities at the National Biologics Manufacturing Centre in Darlington, U.K. FDB 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, Senior Scientific Advisor, Centre for Process Innovation.

“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.

About Fujifilm
FUJIFILM Diosynth Biotechnologies is an industry leading Biologics Contract Development and Manufacturing Organisation. FUJIFILM Diosynth Biotechnologies has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, expressed in a wide array of microbial, mammalian, viral and insect systems. The company offers a comprehensive list of services from cell line development, including its proprietary pAVEway microbial and Apollo mammalian systems to process development, analytical development, clinical and commercial manufacturing. The company has three sites that operate as a network. These are located in Billingham, United Kingdom, Research Triangle Park, North Carolina and College Station, Texas. For more information, visit www.fujifilmdiosynth.com.

FUJIFILM Holdings Corporation, Tokyo, Japan, brings innovative solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies derived from photographic film. Its proprietary core technologies contribute to the fields of healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2018, the company had global revenues of $23.0B, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, visit www.fujifilmholdings.com.

About CPI
The Centre for Process Innovation is a UK-based technology innovation centre and is part of the High Value Manufacturing Catapult. The company uses applied knowledge in science and engineering combined with state of the art development facilities to enable its clients to develop, prove, prototype and scale up the next generation of products and processes. Established to support the UK process manufacturing industry, CPI collaborates with universities, SMEs and large corporations to help overcome innovation challenges. Operating across a broad range of technologies, partners are supported at every stage; from concept to market; business support to technology development; and from scale up to supply chain intervention. CPI consists of dedicated national innovation centres that support industrial biotechnology and biorefining, printable electronics, biologics and formulation. The centres enable advancements in major markets such as healthcare, electronics, food and drink, aerospace, automotive, materials, and energy. These world leading, digitally enabled and open access facilities are available for partners to get their products and processes to market quickly with minimal risk. Utilising strong networks, CPI brings together a range of partners in the delivery of innovation projects, with a common goal of strengthening the UK’s position in High Value Manufacturing.

About The AMECRYS Project
The AMECRYS project commenced in October 2016 following the successful application for funding from the EU’s Horizon2020 programme. The consortium is made up of nine members from academia and industry across four EU-member states. For more information, visit http://www.amecrys-project.eu.