New Manufacturing Platform Promises Major Advances in Cell and Gene Therapy Production

In an exciting development for the field of cell and gene therapy, Ori Biotech has unveiled an innovative manufacturing platform aimed at significantly reducing costs and production times for these advanced treatments. The new platform, named IRO, could revolutionize the manufacturing landscape for cell and gene therapies (CGT).

Ori Biotech’s IRO Platform: Cutting Costs and Time

On Wednesday, Ori Biotech introduced its new CGT manufacturing platform, named IRO, which promises to halve the costs and cut production time by 25%. Ori CEO Jason Foster emphasized the pressing need for such advancements in an interview with Endpoints News. “We’re in a constrained supply environment. We just can’t physically treat enough patients with cell and gene therapies,” Foster said. According to Ori, around 95% of patients do not have access to CGT due to the high costs and long production timelines.

The IRO platform is designed to address these issues by automating and standardizing the most labor-intensive parts of the manufacturing process. Each IRO unit, resembling a white locker, can produce a single patient dose in just two to three days, a significant reduction from the current eight to ten days. This automation not only speeds up production but also reduces the cost per patient, which typically hovers around $500,000.

Foster highlighted the platform’s use of cloud technology, which generates data every seven seconds, providing a comprehensive view of the manufacturing process. This real-time data helps to reduce variability and improve the efficiency of reagent use. Additionally, Ori’s platform can integrate a client’s existing cell therapy manufacturing process within about five weeks, compared to the usual six to nine months.

One of the most striking features of the IRO platform is its compact design. A space no larger than a two-car garage can accommodate approximately 30 IRO units, capable of producing a thousand doses annually. This is a stark contrast to traditional methods, which require a space the size of a four-bedroom house to produce the same number of doses.

Since its launch in January 2020, Ori has secured significant funding, including $9.4 million in seed funding, $30 million in Series A, and $100 million in Series B funding. After five years of development, Ori believes its IRO platform is poised to make a substantial impact on the CGT field.

Addressing the Challenges of Advanced Therapies

Ori’s platform comes at a crucial time for the field of cell and gene therapy, which has seen significant advancements in treating conditions like blood cancers. However, manufacturing limitations have been a persistent bottleneck, hindering wider patient access. Ori estimates that over 95% of patients who could benefit from these therapies are currently unable to receive them due to production hurdles.

At the International Society for Cell & Gene Therapy’s (ISCT’s) 2024 annual conference in Vancouver, Ori emphasized the importance of their new platform in addressing these issues. By automating, digitizing, and standardizing key parts of the CGT manufacturing workflow, Ori aims to make these advanced therapies more accessible and affordable.

Future Prospects

Ori’s IRO platform is expected to be commercially available by the first quarter of 2025. The company has already begun placing its technology with industry experts through its LightSpeed Early Access Program (LEAP), launched in early 2022. Feedback from partners, including a major pharmaceutical company, several CDMOs, and MD Anderson Cancer Center, has helped Ori refine its platform for its commercial debut.

With the ongoing development and deployment of this new platform, the future looks promising for making cell and gene therapies more accessible to patients in need. As these technologies mature and become more widely adopted, they could mark a significant leap forward in the fight against a range of serious diseases.

Source:
https://www.fiercepharma.com/pharma/ori-biotech-charts-commercial-launch-iro-platform-after-5-year-quest-streamline-cell-and
https://endpts.com/ori-biotech-cytiva-separately-unveil-tech-to-accelerate-cell-therapy-production/

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