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GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.
On Sept. 25, 2018, Cobra Biologics (Cobra), a contract development and manufacturing organization (CDMO), announced a collaboration with the Centre for Process Innovation (CPI), a UK-based technology innovation center, and GE Healthcare Life Sciences. The three-way partnership will be funded by a £570, 000 (US$752,000) Innovate UK grant and aims to enhance the manufacturing process as well as reduce costs for the manufacturing of adeno-associated virus (AAV) vectors, a delivery vehicle used for emerging gene therapy treatments.
GE Healthcare’s Puridify fiber-based chromatography technology platform can produce highly purified protein biopharmaceuticals, such as monoclonal antibodies. The collaboration with CPI and Cobra Biologics intends to demonstrate the application of this platform to gene therapy.
The project will extend the advantages of GE Healthcare’s technology and develop a multistep fiber-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 fiber-based technology will then be transferred to CPI, which will run process flowsheets incorporating the technology to demonstrate its suitability for AAV manufacture.
According to Cobra Biologics, 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 a risk that gene therapies will be launched commercially at prices unaffordable to healthcare payers, such as the National Health Service, the company reports.
“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 fiber-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,” said Prof. Daniel Smith, chief scientific officer at Cobra Biologics, in a company press release.
“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 commercialization. Additionally, the project builds on a successful relationship established with Cobra Biologics through an on-going AAV project,” said Dr. John Liddell, CPI senior scientific advisor, in the release.
Dr. Oliver Hardick, business leader, Puridify, GE Healthcare Life Sciences, added: “We are proud to establish this collaboration with Cobra and CPI that seeks to advance technologies for the manufacture of viral vectors that are necessary for emerging gene therapies. Collaboration and bringing together expertise from different fields is critical for improving access to these promising new treatments globally.”
Source: Cobra Biologics