Arecor, CPI and FUJIFILM Diosynth Biotechnologies collaborate

Arecor, CPI and FUJIFILM Diosynth Biotechnologies collaborate to apply smart formulation approaches in the manufacturing of biopharmaceuticals under a grant awarded by Innovate UK

Arecor, the Centre for Process Innovation (CPI) and FUJIFILM Diosynth Biotechnologies have entered into a consortium to collaborate on a two-year R&D project entitled Improved Downstream Operation through Formulation Innovation, supported by grant funding from Innovate UK under its £20 million Industrial Biotechnology Catalyst (IBC) scheme.

The aim of the project is to achieve a step change in biopharmaceutical yield and quality by improving product stability during downstream processing (DSP). The program will focus on utilising Arecor’s innovative and proprietary formulation technology platform. Arecor is the lead party in the consortium and has a proven track record of applying its formulation technology to develop superior liquid stable biopharmaceutical products including therapeutic proteins, peptides and novel format antibodies. In addition, the industrial bioprocessing experience and expertise of FUJIFILM Diosynth Biotechnologies and CPI, will be employed to design predictive scaled down models to enable the implementation of Arecor’s formulation platform to DSP and subsequent scale-up to large scale manufacturing. With a unique combination of expertise across the consortium, this collaboration is expected to deliver a novel formulation platform that can be applied to routine biopharmaceutical manufacturing to deliver significant improvements in the performance of DSP. Specific benefits being sought are improvements in yield, overall protein stability and quality.

The platform will be applied to reduce the production costs of biopharmaceuticals, which will ultimately reduce the cost of therapeutics to healthcare providers. This aligns with the strategic objective of the IBC scheme to enhance the UK’s position as a global leader in this sector.

Quotes from Senior Executives

Arecor: Sarah Howell, Arecor CEO said “The application of Arecor’s innovative biopharmaceutical stabilisation platform to manufacturing is an obvious next step in the evolution of the application of the technology. Given our success in enabling a broad range of superior stable liquid biotherapeutics, we are confident in applying our technology platform to deliver significant improvements to DSP manufacturing and we are excited to have the opportunity to work with our consortium partners under this programme”.

CPI: Dr Chris Dowle, Director of Biologics at CPI said “We are delighted to be working with Arecor and FUJIFILM Diosynth Biotechnologies on this project. By utilising CPI’s knowledge and expertise along with our new National Biologics Manufacturing Centre at Darlington, we will help Arecor develop and demonstrate the application of their formulation platform in downstream processing. This is one of six projects which CPI is involved in as part of the IB Catalyst Funding, re-affirming CPI as one of the collaborators of choice within the sector.”

FUJIFILM: Dr Mark Carver, Senior VP Research, Development and Innovation at FUJIFILM Diosynth Biotechnologies commented “We anticipate that this project will enable us to improve the downstream processing of most classes of biologics, in particular monoclonal antibodies, and lead to improved stability of the drug substance we produce for our customers. We are delighted to leverage Arecor’s expertise in the field of biologic drug formulation, and utilise CPI’s centre of excellence in the development of leading edge biopharmaceuticals.

Company Summaries

About Arecor: Arecor is a leader in enabling superior biopharmaceuticals through formulation technology Innovation. Arecor has developed a proprietary formulation technology platform which has been proven to deliver superior stable liquid biopharmaceutical products that would otherwise not be feasible using conventional formulation science. Many proteins, peptides and vaccines are too unstable in liquid form to develop ready-to-use drugs, or are unstable at high concentrations. Arecor has overcome these challenges to significantly enhance the delivery of therapeutic medicines to patients. It partners with the world’s leading pharmaceutical and biotech companies across a broad range of therapeutic proteins, peptides and vaccines. Arecor is based at the Cambridge Science Park in the UK and has a highly talented scientific team. Please contact us if you would like to discuss our innovative formulation platform technology further via sheridan.cook@arecor.com.

About CPI: The Centre for Process Innovation is a UK-based technology innovation centre and part of the High Value Manufacturing Catapult. We use applied knowledge in science and engineering combined with state of the art development facilities to enable our clients to develop, prove, prototype and scale up the next generation of products and processes.

Our open innovation model enables clients to develop products and prove processes with minimal risk. We provide assets and expertise so our customers can demonstrate the process before investing substantial amounts of money in capital equipment and training. New products and processes can be shown to be feasible; on paper, in the lab and in the plant before being manufactured at an industrial scale.

By utilising our proven assets and expertise companies can take their products and processes to market faster. There is no down time in production as all of the process development is completed offsite and our technology transfer and engineering teams can help companies to transfer the product or process into full scale production at speed.

About FUJIFILM Diosynth Biotechnologies UK Limited: FUJIFILM Diosynth Biotechnologies UK Limited, 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. FUJIFILM Diosynth Biotechnologies is also located in Research Triangle Park, North Carolina, U.S.A. as FUJIFILM Diosynth Biotechnologies U.S.A. Inc. Both sites are FDA-approved for the production of commercial products. The company has a third site in College Station, Texas, U.S.A. known as FUJIFILM Diosynth Biotechnologies Texas, LLC.