As per the agreement, the contract development manufacturing organization (CDMO) is leveraging its Lentivation LVV manufacturing platform and eXpDNA plasmid production platform to manufacture LVVs used in chimeric antigen receptor (CAR) T-cell therapies. Additionally, Charles River will support the institute’s research grade, high-quality plasmid DNA production.
“We are both committed to patient wellness. Charles River [...] fits in with the Gates Institute’s goals to immediately begin clinical CAR-T trials in humans to serve patients in need,” a spokesperson for Charles River told BioProcess Insider.
“The timeline target for GMP lentivirus production utilizing the Lentivation process is as few as seven months. The investigational new drug (IND) filing for Phase I clinical trials using this material is being managed by the Gates Institute. We believe that this foundational partnership for manufacturing could lead to future clinical candidates and in a shorter timeframe to first patient treatment than is typical in the industry.”
Launched in 2023, the Lentivation platform is based on the firm’s set of third generation lentiviral backbone and packaging plasmids. It can cut manufacturing timelines for cell and gene therapies by up to 60%, resulting in less than seven months compared to the usual 18 months, the firm said.
Meanwhile, eXpDNA is Charles River’s trademarked platform approach to manufacture plasmids through a plug-and-play plasmid screening toolbox. According to the firm, the batch turnaround time through this platform is ten weeks for GMP grade plasmid DNA batch.
“With extensive development capabilities and experience, Charles River has the expertise to overcome the challenges that each unique gene of interest (GOI) can present to the performance of the platform manufacturing approach,” the spokesperson added.
“In addition, regulatory requirements can change over time, and the robust Charles River network can develop assays, add new technologies, and address questions from regulatory agencies to meet the evolving demands of the field.”
The Gates Institute mission at the University of Colorado brings together researchers, clinicians, and a GMP biomanufacturing facility for first-in-human clinical trials.
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