Arecor, the Centre for Process Innovation (CPI), and FUJIFILM Diosynth Biotechnologies (FDB) have announced that its collaboration project, entitled “Improving Downstream Operation through Formulation Innovation,” has successfully completed its initial rounds of downstream performance testing of formulations, which have shown very positive results.

The aim of the project, which is on track for completion in November 2017, is to achieve a step change in biopharmaceutical yield and quality by improving product stability during downstream processing (DSP).

To achieve this, the partners are developing a novel formulation platform that can be applied to routine biopharmaceutical manufacturing to deliver significant improvements in the performance of DSP, while also reducing manufacturing costs.

DSP is a critical step for removing impurities and contaminants during the manufacture of biopharmaceutical proteins, owing to the high levels of purification that these drugs require.

However, DSP activities can in fact cause product destabilisation because of 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 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 owing to instability of the conditions required for purification.

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 Adviser, Centre for Process Innovation.

“FDB is delighted to be collaborating with Arecor and CPI on new downstream processing platforms as part of our ongoing 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.