Collaboration to Improve Downstream Processing

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. However, DSP activities can in fact cause product destabilisation due to the stresses imposed, which can result in degradation, aggregation and loss in yield. DSP accounts for approximately 60% of the biopharmaceuticals manufacturing cost and thus requires new technology and development approaches, in order to improve on yield, as well as overall protein stability and quality. The novel formulation platform being developed by the collaboration will meet this need and will be applied to reduce the production costs of biopharmaceuticals, and ultimately reduce the cost of therapeutics to healthcare providers. These new formulations may also enable the production of biotherapeutics that are currently very difficult or impossible to manufacture due to instability to the conditions required for purification.

In order to develop the novel formulation platform for improving DSP, the collaboration set out to identify smart formulations that confer improved product stability during areas of DSP where protein is most sensitive to degradation including, ultrafiltration/​diafiltration, product intermediate hold steps, and chromatography. The project uses Arecor’s innovative and proprietary technology platform, Arestat™, which delivers superior liquid biopharmaceutical products. The platform includes proprietary formulation approaches to significantly improve the aqueous stability of therapeutic proteins, peptides, and novel format antibodies. The industrial bioprocessing experience and expertise of FDB and CPI, together with the formulation expertise of Arecor, were brought together to develop and test novel Arecor protein stabilisation formulations for DSP applications. Downstream formulations were developed through several rounds of screening at Arecor combined with assessment of downstream process impact of the selected formulations testing high throughput, automated liquid handling platforms at CPI’s National Biologics Manufacturing Centre. Following selection of the preferred formulations, development of data to support DSP application of the approach will be generated at CPI with additional tests of unit operations, singly and in combination.

The project is supported by grant funding from Innovate UK under its £20 million Industrial Biotechnology Catalyst (IBC) scheme.

“Improved efficiency and quality is a clear goal for downstream processing operations as they struggle to support recent advances in formulations which have led to large improvements in upstream yields. This encouraging early data is the first step in demonstrating how, through Arecor’s unique stabilisation technology and CPI’s and FUJIFILM Diosynth Biotechnologies DSP expertise, a novel downstream processing formulation platform developed during the project has the potential to deliver lower cost biopharmaceuticals with improved quality profiles,” said David Gerring, Head of Development, Arecor Ltd.

“CPI is delighted to be working with Arecor and FUJIFILM Diosynth Biotechnologies on this project, which has been showing very positive results. This promising work brings us a step closer to achieving the collaboration’s goal of developing a novel downstream processing formulation platform that can be applied to routine biopharmaceutical manufacturing, to deliver significant improvements in the performance of downstream process operations with reduction in manufacturing costs,” said Dr John Liddell, Senior Scientific Advisor, Centre for Process Innovation.

“FDB is delighted to be collaborating with Arecor and CPI on new downstream processing platforms as part of our on-going technology development activity and our commitment to lead the global Biologics CDMO industry through the continuous innovation of technologies, service delivery and quality for the benefit of our customers and their patients,” said Dr Andy Topping, Chief Scientific Officer, FUJIFILM Diosynth Biotechnologies.

Notes to the Editor

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 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 FUJIFILM Diosynth Biotechnologies

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 opeate as a network. These are located in Billingham, United Kingdom, Research Triangle Park, North Carolina and College Station, Texas. . For more information visit Fujifilm Diosynth Biotechnologies