Innovate UK funded project supports development of scalable, cost effective production of regenerative medicines.
Cobra Biologics (Cobra), an international contract development and manufacturing organisation (CDMO) of biologics and pharmaceuticals, today announced a collaboration with the Centre for Process Innovation (CPI), a UK-based technology innovation centre and Cytiva. 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.
Puridify fibre technology from Cytiva
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Cytiva’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 Cytiva’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.
Prof. 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 Cytiva 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.”
Dr. John Liddell, CPI Senior Scientific Advisor, said: “CPI is delighted to be working with Cytiva 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.”
Dr. Oliver Hardick, Business Leader, Puridify, Cytiva, said: “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.”
Cobra Biologics is a leading international contract development and manufacturing organisation (CDMO) providing biologics and pharmaceuticals for pre-clinical, clinical and commercial supply to an international customer base.
Each of Cobra’s GMP approved facilities are tailored to serving our customers around the world. We offer a broad range of integrated and stand-alone contract development and manufacturing services for clinical trials and the commercial market.
As a trusted provider and a key partner in the drug development and commercialisation process, we take pride in our manufacturing excellence and comprehensive range of services to the pharmaceutical and biotech industries.
At CPI we work with our partners to develop products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries. In doing so, we support the development of next-generation manufacturing organisations which require highly-skilled jobs, and will result in sustained economic growth for the UK.
Our partners operate across diverse markets including Healthcare, Food & Agriculture, FMCG, Electronics, Energy, Transportation and Construction. CPI is able to support such a broad-base of industries through our unique innovation processes, together with our diverse and expanding platform of technological expertise.
Overall the combination of CPI’s innovation processes and our outstanding scientific expertise enables our partners to get more products to market faster, and at a lower overall cost.