Despite clinical success, cell and gene therapy pipelines are stunted. The core issue is a broken business model, where therapies are difficult to distribute globally and profitably. A scalable manufacturing platform is the key to enabling profitability, which in turn fuels reinvestment into new therapies.
To handle delicate primary cells, Ori Biotech designed a single bellows-based bioreactor that operates in multiple modes: static (T-flask), rocked (wave reactor), or with low-shear plunging (stirred tank). This flexibility allows optimization of different process steps like activation, transduction, and expansion within the same container.
Instead of designing a novel sterile connection system, which is risky, Ori Biotech miniaturized and multiplexed the proven "paper pull tab" system. This approach leverages a trusted, decades-old technology to build reliability and gain acceptance for their innovative automation platform.
The true scalability problem in cell therapy isn't just manufacturing but the mountains of paperwork for QA/QC. Ori Biotech's solution is a fully digitized ecosystem that captures every action, sensor reading, and integrates analytical equipment results directly into a cloud-based digital batch record.
To make hospital-based manufacturing feasible, complex material preparation (e.g., thawing and formulating viruses) must be eliminated. Ori Biotech's model allows partners to pre-fill consumables at a central facility. These are then shipped frozen and ready-to-use, de-skilling the process at the point of care.