Regulatory Partnership to develop cost effective regenerative medicine

Cobra Biologics, an international contract development and manufacturing organisation (CDMO) of biologics and pharmaceuticals, will collaborate with the Centre for Process Innovation (CPI), a UK-based technology innovation centre and GE Healthcare Life Sciences.

The three-way partnership, funded by a £570K Innovate UK grant, aims to increase the robustness and reduce costs for the manufacturing of adeno-associated virus (AAV) vectors, a delivery vehicle used for emerging gene therapy treatments. The gene therapy area has been developing rapidly and while only a small number of treatments are already approved for use, more than 200 clinical trials are underway.

AAV vectors are effective and versatile, but their use in clinical trials is hampered by complicated production processes. Without improvements to manufacturing approaches and better process understanding, there is the risk of gene therapies being launched commercially at prices unaffordable to healthcare payers, such as the NHS.

GE Healthcare’s Puridify fibre-based chromatography technology platform, can achieve high purification productivity of protein biopharmaceuticals, such as monoclonal antibodies. The collaboration with CPI and Cobra Biologics will help demonstrate the application of the purification platform to gene therapy, helping to provide more efficient and scalable gene therapy manufacturing and more affordable therapies.

The project will extend the advantages of GE Healthcare’s technology and develop a multistep fibre-based chromatography purification process for AAV. These viral vectors will be produced in-house by Cobra Biologics and CPI using a system developed via an ongoing Innovate UK grant. The developed fibre-based technology will then be transferred to CPI, where entire process flowsheets incorporating the technology will be run to demonstrate suitability for AAV manufacture.

Professor Daniel Smith, Chief Scientific Officer at Cobra Biologics, said: “The scalable chromatographic purification of recombinant AAV-based viral vectors for use in gene therapy applications remains an area of intense global development, essential to support the rapidly increasing market opportunity for these innovative medicines."

"As such, Cobra Biologics is pleased to be collaborating with both GE Healthcare Life Sciences and CPI as part of this Innovate UK funded project. The application and implementation of the fibre-based chromatography for the purification of AAV vectors could provide a step change in the technology available, allowing for the scalable, cost effective production of this emerging class of innovative medicines.”

Dr John Liddell, CPI Senior Scientific Advisor, said: “CPI is delighted to be working with GE Healthcare Life Sciences and Cobra Biologics on this exciting project working to help develop robust and efficient downstream processes for the rapidly developing area of gene therapy."

"Gene therapies have the potential to be transformative for areas of unmet clinical need and effective manufacturing processes, which are the subject of this project, will be important enablers to achieving commercialisation. Additionally, the project builds on a successful relationship established with Cobra Biologics through an on-going AAV project.”