Reflections on Achieving Commercial-Scale CGT Manufacturing Capability (Part 1)

Jason Foster, CEO and executive director of Ori Biotech, spoke with BioPharm International® about the significance of the company’s proprietary automated cell and gene therapy (CGT) manufacturing platform, IRO, demonstrating the ability to simultaneously deliver superior biological performance and the benefits of automation to help address the challenges of commercial-scale manufacturing, following an announcement in September 2024 (1). The IRO system increases throughput by 10–50 times, reduces costs by 30–50%, and improves quality, Foster explains.

“You get better biological results, and you get better performance of your manufacturing process, so more products come out in spec, meaning that they can go to the patient, and they're safe and effective," Foster says.

Foster emphasizes how CGTs are highly complex, personalized medicines that require specialized manufacturing processes. Unlike traditional pharmaceuticals, these therapies involve working with living cells that must be carefully handled, preserved, and transported.

“Current manufacturing processes are highly manual, expensive, and prone to high variability and low throughput,” he states. “The IRO platform addresses a critical bottleneck in the manufacturing process of cell and gene therapies.”

It is this critical bottleneck that limits patient access to these potentially life-saving treatments, he adds. Addressing these manufacturing challenges is the core focus of Ori Biotech's technology platform, which aims to significantly improve throughput, reduce costs, and enhance the quality and consistency of CGT manufacturing. The company has partnerships with major pharma, biotech, and academic institutions in place, with the first commercial products delivered. Foster says that the company expects to receive good manufacturing practice certification by mid-2025.

Click above for the full interview.

About the speaker

Jason C. Foster, CEO and Executive Director, Ori Biotech

Jason C. Foster has held leading roles in consulting, healthcare and technology companies for more than 20 years in the United States, United Kingdom, and Europe, and is currently CEO and executive director for Ori Biotech, a cell and gene therapy manufacturing technology company. In addition, as the managing director of Health Equity Consulting (HEC) for the past six years, Foster has advised private equity and venture capital funds, family offices, accelerators and healthtech start-ups. Foster is also a strategic advisor to Joyance Partners, a Venture Partner with Hambro Perks and is active in mentoring healthtech startups as co-chair of the Tech London Advocates healthtech working group. Foster also volunteers as a trustee for the UK-registered charity, Painkiller Addiction Information Network.

Reference

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.