Tackling Critical CGT Bottlenecks and Envisioning the Future (Part 2)

In the second half of an interview with BioPharm International®, Jason C. Foster, CEO and executive director of Ori Biotech, emphasizes how cell and gene therapy (CGT) manufacturing faces significant bottlenecks, primarily in the cell processing phase where activation, genetic reprogramming, and expansion occurs. This cell processing phase takes about seven to 10 days, and is the main constraint, particularly with cell therapies. In comparison, the initial thawing, selection, and washing steps take only about four to six hours, Foster explains.

Ori Biotech’s automated IRO manufacturing platform addresses this bottleneck by aiming to shorten the cell processing phase to five to six days and enable parallel processing of 30 patients simultaneously. With this configuration, throughput can be increased by 10–50x, depending on how many IRO platforms are in operation, Foster says.

Meanwhile, in the downstream processing stage, batch release and quality control processes become the next bottleneck. Foster points out that the industry's goal was to treat hundreds of thousands of patients annually, but the current capacity is limited to an estimated 10,000 patients by 2024. The key challenge, he highlights, is making these therapies commercially viable and affordable, as approved products are often inaccessible due to high costs.

Looking ahead, Foster notes, the biggest opportunities lie in expanding beyond hematological cancers to solid tumors and autoimmune diseases. These disease areas have large patient populations and limited treatment options. Manufacturing scale-up remains a critical hurdle, however, and innovative solutions to streamlining production and quality control will be essential to make cell and gene therapies accessible to millions of patients in need, Foster says.

Click above for the full interview.

Click here for part 1 of the 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.