Cell and gene therapy (CGT) biotechnology company Ori Biotech has collaborated with contract development and manufacturing organization (CDMO) Charles River Laboratories (CRL) to accelerate cell-therapy production using the former firm’s CGT-manufacturing platform. According to Ori Biotech, the IRO platform reduces labor by up to 70%, costs by up to 50%, and process time by up to 25%. 

Earlier this year, CRL joined Ori’s LightSpeed Early Access Program (LEAP) designed to provide access to the IRO platform. The program provides the CRL with feedback from customers about their needs, helping to ensure an adaptable and dynamic product before commercial launch.  

During the collaboration, Ori and CRL conducted head-to-head process runs comparing the IRO platform's biological performance with a process CRL specifically optimized for CAR-T therapy.   

BioProcess Insider spoke to Matt Hewitt, the chief technology officer for CRL and Jason Foster, the CEO of Ori Biotech to find out more. 

BioProcess Insider (BPI): How did the collaboration between CRL and Ori Biotech come about, and what were the key factors that led to this partnership? 

Matt Hewitt (MH): As part of this collaboration, the IRO platform was used in one of the CRL’s facilities to demonstrate comparability to another method of manufacturing cell-therapy products. It is CRL’s responsibility to be aware of and understand the use-cases for new technologies like the IRO so we can provide the best-fit technology for a particular program which is, many times, striving to manufacture potentially curative therapies for patients with high unmet therapeutics needs. 

BPI: How will the collaboration between Ori Biotech and CRL enhance the manufacturing of CGTs, particularly in terms of scaling production?   

Jason Foster (JF): As part of this collaboration, CRL conducted three studies consisting of head-to-head comparisons between the IRO platform and a commonly used automation platform.   

IRO automates the key manufacturing workflow bottleneck of activation, transduction, expansion, and harvest. This allows for faster scaling by reducing both tech transfer and manufacturing process times, all while increasing throughput per square foot. With the capability to produce 1,000 products a year in just 1,000 square feet of cleanroom space, the platform shows strong potential to efficiently scale from research and development (R&D) to GMP. 

BPI: What specific CGTs are targeted for manufacturing using the IRO platform through this collaboration?  

JF: The IRO can manufacture up to 12 billion cells within a single run using the current consumable. While the IRO platform was optimized specifically for chimeric antigen receptor (CAR-T) therapy, it has been used in many different cell types including TILs, TCRs, NKs, CD34s, and Dendritic cells.    

BPI: How will CRL use the IRO platform? 

MH: We intend to continue the collaboration with the IRO to assess different workflows and understand its full capabilities and features. This will include potentially running additional studies examining how best to utilize the IRO in a non-viral manufacturing process. In parallel, we will work with our clients to understand whether the IRO technology is fit-for-purpose for their program, and we will have the requisite knowledge to quickly and smoothly move any potential program seeking to use the IRO for clinical manufacturing into our GMP facility. 

BPI: What are the main challenges in gene-therapy manufacturing that the IRO platform addresses, and how will this collaboration with CRL accelerate the delivery of life-saving therapies to patients?  

JF: The IRO platform is designed to help address manufacturing bottlenecks that result in patient waitlists for manufacturing slots that put critically ill patients at risk.  The collaboration with CRL helps refine and optimize the IRO platform to ensure it accelerates the development and delivery of therapies. 

BPI: How does the IRO platform's automation capabilities compare to CRL’s previously optimized CAR-T manufacturing process?  

MH: The IRO performed extremely well against other systems with which CRL has more experience. These comparability exercises were common in the field, including in CDMOs, to help our teams and clients understand the best-fit technology for their program.  

BPI: Are there plans to expand IRO's use across other types of therapies beyond CAR-T therapies?

MH: The CRL teams do have plans to look at how the IRO platform can manufacture cell products other than CAR-T therapies.