“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 innovate 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, chief executive officer of Cobra Biologics.
“Yields for downstream processing of AAV are currently very low and the production process is costly in both time and consumables,” said Mario Philips, vice president and general manager of Pall Biotech. “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, chief executive officer 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.”
The transition from batch to continuous chromatography will be planned and managed by all parties. The project began in September 2018.