London and Philadelphia-based Ori Biotech has announced a strategic collaboration with an undisclosed biopharmaceutical company to potentially switch the partner’s autologous cell therapy manufacturing infrastructure to Ori’s automated IRO platform.  

The deal, valued at up to $120 million in services, milestones, equipment and consumable purchases over 10 years, seeks to integrate Ori’s IRO platform into the biopharma company’s commercial cell therapy manufacturing process. The goal of the partnership is to demonstrate the comparability of IRO to the existing commercial production process.

By automating and digitizing critical processes, Ori contends IRO is designed to streamline production workflows to overcome autologous cell therapy production challenges that limit clinical and commercial success. At the same time, IRO supports both research and development and GMP manufacturing on the same system.

“The IRO platform automates better biology by combining proprietary hardware, consumables, software and data analytics in a closed, GMP-ready system,” according to Ori. “IRO addresses the core challenges of autologous cell therapy production: reducing batch-to-batch variability, minimizing operator touch time, increasing throughput, and lowering COGS — while improving the biological performance that often determines clinical outcomes.”

Last year, the IRO platform received the U.S. Food and Drug Administration’s Advanced Manufacturing Technology (AMT) designation, which Ori contends will potentially enable developers using the automation platform to have earlier and more frequent FDA engagement, accelerating regulatory filings.

While Ori has racked up 23 partners since IRO’s launch in 2024, CEO Jason Foster told Pharma Manufacturing that Tuesday’s announcement about a partnership with an undisclosed biopharma company is the most important relationship it has formed to date.

“The fact that this is an already approved product — that’s in the market and treating patients — is a massive differentiator and leap forward,” Foster said. “This partner is evaluating whether or not to switch their core, existing manufacturing capability to utilize IRO.” 

Although the biopharma partner’s identity will remain confidential for competitive reasons, Foster noted the company is “one of the seven developer therapy companies that have an approved product in the U.S. as an autologous cell therapy.”

Ori rival Cellares loses BMS customer  

Ori’s new 10-year, $120 million collaboration with the biopharma company comes on the heels of a setback for rival Cellares, which recently lost Bristol Myers Squibb as a partner after the drugmaker determined that Cellares’ Cell Shuttle system “could not meet the necessary requirements to make commercial Breyanzi.”

In a statement to Pharma Manufacturing, Cellares strongly disagreed with Bristol Myers Squibb’s characterization of why the partnership ended. “The Cell Shuttle has already manufactured GMP drug product in an FDA-regulated clinical program, with doses meeting all release specifications, delivered on time and administered to patients,” a Cellares spokesperson said. 

Both Cellares and Ori are looking to automate cell therapy manufacturing. However, Foster sees a clear advantage for Ori’s technology compared to its competitors. He argues that “inflexible, end-to-end platforms” such as Cellares’ Cell Shuttle and Octane Medical Group’s Cocoon have always had difficulty delivering the biological performance required.

“When you use a cartridge-based approach or a fixed approach of any kind, there are limitations,” Foster said, adding that he’s “not intending to throw the Cell Shuttle or Cocoon under the bus.”

Like Ori’s IRO system, the Cell Shuttle and Cocoon platforms have each received the FDA’s AMT designation. In early 2026, global contract development and manufacturing organization Lonza divested to Octane its personalized medicines cell and gene therapy business, including the Cocoon platform.