Charles River, Ori Biotech Cell Therapy Manufacturing Platform Collaboration Yields Promising Results

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Charles River Laboratories, headquartered in Wilmington, Mass., and Ori Biotech, a manufacturing technology company with hubs in London and Philadelphia, jointly announced on Sept. 18, 2024, some results of a collaboration between the two companies that began earlier in 2024, with Charles River using Ori’s LightSpeed Early Access Program to access Ori’s next-generation cell and gene therapy manufacturing platform, known as IRO (1).

Head-to-head process runs compared IRO’s biological performance to a process optimized by Charles River specifically for chimeric antigen receptor (CAR)-T cell therapy, over two years, with an alternative manufacturing technology.

The Ori Biotech platform’s performance outdistanced the legacy technology, Prodigy, with an average of 51% CAR+ expression and 2.1 billion total CAR+ cells, in a seven- to eight-day process, versus 1.6 billion CAR+ cells in the legacy technology, according to the press release (1).

“We are excited to share [these] 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,” said Jason C. Foster, CEO of Ori Biotech, in a press release (1). “For too long, therapy developers have had to sacrifice biological performance for automation, but not anymore. IRO automates better biology to solve critical manufacturing bottlenecks and improve product viability by dramatically increasing throughput, decreasing COGS [cost of goods sold], and reducing batch failures, with the ultimate goal of enabling widespread patient access to life-saving cell and gene therapies.”

Ori Biotech’s website said IRO is compatible with all suspension cell therapies, has achieved higher transduction efficiency and cell yields than the contemporary “gold standard” cell expansion system, reduces manufacturing process times by an average of one to two days, and mitigates risk of process change and comparability between the clinical and commercial stage (2). The company said the platform is good manufacturing practice (GMP)-ready—enabling manufacturing in GMP Grade C or D cleanrooms—and 21 Code of Federal Regulations (CFR) Part 11 compliant, able to increase throughput per square foot to the tune of approximately 1000 doses per year in 1000 sq. ft.

“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,” Matthew Hewitt, PhD, vice president, CTO Manufacturing Business Division, Charles River, said in the press release. “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.”

To put some numbers on the advantages the two companies’ executives touted, Ori Biotech said that IRO has the potential to reduce labor up to 70%, cut cost of goods by up to 50%, reduce processing times by approximately 25%, and reduce tech transfer times from months to weeks (1).

References

1. Ori Biotech. Ori Biotech and Charles River Laboratories Collaborate to Accelerate Life-Saving Cell and Gene Therapy Development and Manufacturing. Press Release. Sept. 18, 2024.

2. Ori Biotech. IRO. oribiotech.com/iro (accessed Sept. 23, 2024).