Application Note

Scalability: Consistent And Reproducible Manufacturing Across A Multi-IRO® System

Source: Ori Biotech
Contamination Risk Mitigation In Cell Culture Media

An important challenge in cell and gene therapy manufacturing is ensuring consistent, reproducible results from batch to batch. This is especially true when scaling up production, which often involves using multiple manufacturing platforms. In a recent study, T cells from five different donors were manufactured in parallel using the IRO platform, with a standardized process to assess the system's ability to deliver consistent results. The data demonstrates high reproducibility across multiple IRO platforms, with low inter-platform variability for key metrics.

The coefficient of variation (CV) was less than 3% for viable cell yield, less than 5% for transduction efficiency, and between 3% and 7% for T cell phenotype. This consistency in biological performance makes the IRO platform a reliable solution for scalable T cell manufacturing, helping maximize clinical and commercial impact. To learn more, explore the full application note.

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