A collaboration project among Arecor, the Centre for Process Innovation (CPI), and FUJIFILM Diosynth Biotechnologies (FDB), entitled ‘Improving Downstream Operation through Formulation Innovation’ has successfully completed its initial rounds of downstream performance testing of formulations, with positive results. The project aims 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 with the goal of delivering improvements in the performance of DSP, while also reducing manufacturing costs.
 
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 technology platform, Arestat to deliver liquid biopharmaceutical products using approaches to improve the aqueous stability of therapeutic proteins, peptides, and novel format antibodies.
 
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.
 
“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.
 
“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.