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Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.
Cobra Biologics, a contract development and manufacturing organization (CDMO) that focuses on advanced therapy medicinal products (ATMPs), has received a £1.5-million (US$1.9-million) grant from Innovate UK, the United Kingdom’s innovation agency, to investigate continuous manufacturing of adeno-associated virus (AAV) vectors for gene therapy. Sharing this grant are Pall Corp., a specialist in downstream biopharmaceutical processing, and Cell and Gene Therapy Catapult, an independent research and technology organization that is dedicated to advancing the growth of cell and gene therapy in the UK.
“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. 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,” said Peter Coleman, CEO of Cobra Biologics, in a company press release.
“Yields for downstream processing of AAV are currently very low and the production process is costly in both time and consumables,” explained Mario Philips, vice-president and general manager of Pall Biotech, in the press release. “With this project, we hope to advance the AAV purification process and affect a 25% or more step change in purification yields. 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.”
“Our shared vision is to take a major step towards continuous processing for gene therapy production. We each bring strengths and a unique perspective to this collaborative R&D project,” added Keith Thompson, CEO of the Cell and Gene Therapy Catapult. “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. We are excited to play a key role in increasing patient access to these potentially life-changing therapies and to further establish best practices in manufacturing.”
All three partners will plan and manage the process’ transition from batch to continuous chromatography. Their work began in September 2018.
Source: Cobra Biologics