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Investigating continuous manufacturing of AAV for gene therapies
11-27-2018
by Jeffrey Bouley  |  Email the author
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LONDON, KEELE, U.K. & PORT WASHINGTON, N.Y.—Cobra Biologics, a contract development and manufacturing organization (CDMO) with a focus on advanced therapy medicinal products (ATMPs), announced Nov. 26 that it had won a £1.5-million shared grant from Innovate UK, the United Kingdom’s innovation agency. Working with its co-winners for the grant, Cobra and its partners will investigate continuous manufacturing of adeno-associated virus (AAV) for gene therapy applications.
 
In on this grant with Cobra are Pall Corp., which focuses on filtration, separation and purification technology and processes, and the Cell and Gene Therapy Catapult, an independent research and technology organization focused on advancing the growth of the United Kingdom’s cell and gene therapy industry.
 
While the announcement of the grant is very recent, the project actually began in September of this year, and that trio says that “The transition from batch to continuous chromatography will be planned and managed by all parties.”
 
“In light of the unprecedented clinical successes with a number of ATMPs, we are looking forward to working with Pall and the Cell and Gene Therapy Catapult,” said Peter Coleman, CEO of Cobra Biologics. “Together we will develop innovative in-process analytical techniques and manufacturing approaches based on continuous chromatography platforms, to significantly increase process yields, and, in doing so, make these advanced therapies more accessible to patients.”
 
Mario Philips, vice president and general manager of Pall Biotech, noted that yields for downstream processing of AAV are currently “very low” and also pointed out that the production process is costly—both in terms of time spent and consumables used. “With this project, we hope to advance the AAV purification process and affect a 25-percent or more step change in purification yields,” he explained, adding: “The Pall Cadence BioSMB system will be investigated for its ability to increase yields and decrease cost, while using novel analytical procedures to enhance the purification process.”
 
Over at the Cell and Gene Therapy Catapult, CEO Keith Thompson said it was the shared goal of the three organizations to make a major leap forward in terms of continuous processing for gene therapy production, noting that “We each bring strengths and a unique perspective to this collaborative R&D project. As we move forward, we will create a scalable continuous process that increases efficiencies in time and cost, to make commercialization of gene therapies safer, faster, and cheaper than ever before.”
 
In other recently announced news from Cobra related to viral vector gene therapy products, the international CDMO noted in very late October that it and the University of Leeds had been awarded £100,000 to investigate the effects of hydrodynamic force on the structure and biological integrity of viral vector gene therapy products.
 
The project between Cobra and Dr. David Brockwell at the University of Leeds seeks to ultimately create a new analytical tool for gene therapy vector characterization using a device that generates a defined and controllable extensional hydrodynamic fluid flow field. This kind of technology would be used to help optimize the conditions for the successful manufacture of viral vectors and to identify inherently stable viral vectors for gene therapy applications.
 
The proof-of-concept grant that parties won is funded by the Biotechnology and Biological Sciences Research Council (BBSRC) Networks in Industrial Biotechnology and Bioenergy (NIBB) BioProNET, a network that brings together academics, industrialists and others for collaborative research in the field of bioprocessing and biologics.
 
Brockwell, along with Prof. Nik Kapur and Prof. Sheena Radford, previously developed an extensional flow instrument to understand the deleterious effects of bioprocessing on therapeutic proteins, such as antibodies. The collaboration with Cobra will aim to determine whether the device can be used to direct the development of gene therapy viral vectors by helping to define flow parameters, optimize buffer solutions or design scaffolds—as well as whether it can be used as an analytical tool to differentiate between vectors with empty or full payloads.
 
Speaking for Cobra Biologics, Coleman said, “This collaboration with the University of Leeds highlights Cobra’s desire to innovate alongside leading academics and further develop its manufacturing and analytical platforms for the production of gene therapy vectors. We are always striving to improve upon the technical solutions we offer to reduce time and cost to the clinic for our customers.”
 
As for Brockwell—an associate professor in the School of Molecular and Cellular Biology at the University of Leeds—added: “The instrument we’ve developed has the potential to make a significant contribution to the bioprocessing industry. By identifying and refining the conditions required for optimal production utilizing the manufacturing expertise at Cobra Biologics, we hope to be able to develop a timely and cost-effective solution for processing gene therapy vectors.”
 
In slightly older news from late September, Cobra also announced a collaboration with the Centre for Process Innovation (CPI), a United Kingdom-based technology innovation centre and GE Healthcare Life Sciences. The three-way partnership, funded by a £570,000 Innovate UK grant, aims to increase the robustness and reduce costs for the manufacturing of AAV vectors.
 
GE Healthcare’s Puridify fiber-based chromatography technology platform is said to be able to achieve high purification productivity of protein biopharmaceuticals, such as monoclonal antibodies, and the work between CPI and Cobra Biologics will look to 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 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,” said Prof. Daniel Smith, chief scientific officer at Cobra Biologics. “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.”
 
Added Dr. John Liddell, CPI’s senior scientific advisor: “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.”
 
Code: E11281802

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