Charles River Laboratories International Inc.
09/18/2024 | News release | Distributed by Public on 09/19/2024 10:39
Innovating Cell Therapy Manufacturing
Cell and gene-modified cell therapies are experiencing tremendous growth as the potential to produce life-saving treatments becomes fully realized. But as these new therapies are discovered, the ability to scale manufacturing to produce enough treatments for patients in need continues to fall short.
As part of our commitment to bridging that gap and in researching leading-edge technology, Charles River has collaborated with Ori Biotech to demonstrate the capabilities of Ori's next-generation CGT manufacturing platform called IRO® (ee-RO).
The IRO platform was unveiled earlier this year at the International Society for Cell & Gene Therapy's 30th annual conference (ISCT 2024) in Vancouver, BC.
After months of validating the IRO's performance, Matthew Hewitt, Charles River Laboratories Vice President, CTO Manufacturing, and Jason C. Foster, Ori Biotech CEO, presented new scientific data for the platform alongside in-person demos on September 17 in Boston, MA, leading up to the 9th annual CAR-TCR Summit.
Optimizing CAR-T Processes
The IRO automates, digitizes, and standardizes the most time-consuming and labor-intensive parts of the cell and gene therapy manufacturing workflow, giving developers the ability to quickly optimize processes.
According to Ori, by reducing labor by up to 70%, reducing the cost of goods by up to 50%, cutting processing times by up to 25%, and accelerating tech transfer times from months to weeks, IRO could shave years off therapy development timelines.
"For too long, therapy developers have had to sacrifice biological performance for automation, but not anymore. IRO automates better biology solving the critical manufacturing bottlenecks to improve product viability by dramatically increasing throughput, decreasing COGS, and reducing batch failures, with the ultimate goal of enabling widespread patient access to life-saving cell and gene therapies." said Jason C. Foster, CEO, Ori Biotech, in a recent press release.
As part of Ori's LightSpeed Early Access Program (LEAP), Charles River has been collaborating with Ori since the beginning of the year to conduct head-to-head process run comparisons. Charles River compared the IRO platform's biological performance to a process Charles River specifically optimized for CAR-T therapy over two years using an alternative cell therapy manufacturing technology.
With minimal process optimization, the IRO platform performed at least as well in some metrics and outperformed the current process in both cell growth and total CAR+ cells out of the box. IRO achieved an average of 51% CAR+ expression and 2.1 billion total CAR+ cells in a 7- to 8-day process versus 1.6 billion total CAR+ cells in the legacy manufacturing technology.
Advancing Process Optimization for Better T Cell Therapies
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Scalable Cell Therapy Manufacturing
As the field of cell therapy rapidly evolves, Charles River's Process Development Team extensively researches and tests the latest technology while offering expertise in commercial viability and regulatory compliance.
As a full-service CDMO with over 20 years of experience in cell and gene therapy development and manufacturing, we have established optimized, scaleable production processes that propel drug candidates forward and ensure consistent quality of the final product.
Explains Matt Hewitt, VP, CTO Manufacturing, Charles River Laboratories, "Charles River's work with Ori is part of a larger commitment to improve and scale advanced therapies through the adoption of cutting-edge closed and automated platforms to meet the growing patient demand for life-saving therapies. The test of Ori's new IRO platform using head-to-head process transfer runs shows promising results and provides therapeutic developers another option for manufacturing and helps to address the manufacturing bottleneck challenge."
Adds Foster, "We are excited to share this data from our ongoing partnership with Charles River, showcasing the IRO platform's ability to simultaneously deliver both superior biological performance and the benefits of automation."
For more information on our cell therapy development and manufacturing, please visit Cell Therapy Manufacturing Services.