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The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.
CPI, an independent technology innovation center that specializes in bringing together academia, businesses, government, and investors, announced on Oct. 22, 2019 that its CRD IUK project was successful in developing a scalable, cost-effective purification process for adeno-associated viruses (AAVs) in partnership with Cobra Biologics and GE Healthcare Life Sciences. The new process will remove a significant bottleneck in the development of gene therapies and speed their time to market.
AAVs have become the most important technology for in-vivo delivery of gene therapy products, transporting genetic material into patient cells to provide a cure for otherwise untreatable diseases, according to CPI. However, there are significant challenges associated with AAV production and purification. The low efficiency of AAV production slows down the overall development timescale of gene therapies and increases the cost for payers in healthcare systems, thus reducing their availability to patients in need.
The CRD IUK project was funded by a £570,000 (US$735,000) grant from Innovate UK and focused on optimizing an AAV purification process using GE Healthcare Life Sciences’ Fibro chromatography material. The Fibro material is based on electrospun cellulose nanofibers that are derivatized with different chromatography functionalities. The material overcomes both the capacity and recovery limitations of existing chromatographic supports. The technology was known to be highly effective for purification of biomolecules such as monoclonal antibodies, and the CRD IUK project extended knowledge of that effectiveness to species the size and complexity of AAVs.
Initially, CPI carried out an assessment of the Fibro technology and generated data supporting its application to AAV purification. Results demonstrated that, in spite of the size of AAV particles, high flowrates and high capacities were achievable, in turn providing high productivities and yields with small, single-use chromatography devices. Subsequently, an industrially relevant, robust, multistep purification process was developed for AAV purification incorporating Fibro chromatography. The new process was shown to be simple, rapid, and suitable for biomanufacturing.
“We are delighted to have been part of this collaboration working to develop robust processes for use in the development of gene therapies. This project has provided a scalable, cost-effective fiber-based chromatography method for production of AAVs that will greatly enhance development of innovative new treatments,” said Daniel Smith, chief scientific officer, Cobra Biologics, in a company press release.
“Gene therapies have the potential to be transformative for disease areas with unmet clinical need, and effective manufacturing processes are crucial for reaching the time and cost points necessary for achieving commercialization. This was the second Innovate UK-funded project related to viral vectors for CPI and therefore further enhances the Catapult center’s ability to support growth of this emerging sector, which has been confirmed in subsequent gene therapy projects,” added John Liddell, chief technologist, CPI, in the press release.
“This has been an excellent collaboration with Cobra Biologics and CPI. Together, we have made a big step forward in the production of viral vectors to be used in gene therapies. The success of the project will significantly reduce the cost and time associated with development and manufacturing of AAVs, helping to accelerate delivery of gene therapy products to market,” said Oliver Hardick, business leader, Puridify, GE Healthcare Life Sciences, in the press release.