BetaEntity Annotation Prototype
← Back to drugs

Annotated abstract

211 Negative selection microbubble T cell isolation for healthier cells: a scalable, closed-system manufacturing workflow

jitc · 2025-11-04 · canonical JSON source

1 visible annotations · policy: published · automated confidence ≥ 75.00%

Document resource

Background To broaden access and reduce costs, cell therapy manufacturers would benefit from a workflow that has limited equipment dependency, is readily scalable, and is a closed-system solution that preserves cell health. Traditional magnetic isolation utilizes a positive selection approach, where magnetic particles directly contact the cells of interest and instruments required to scale increase complexity, cost, and processing time while potentially compromising cell health. Microbubbles present an innovative, alternative solution to magnetics, delivering highly pure, truly untouched cells faster, with improved viability and scalability to greater than 50 billion cells. The buoyant nature of microbubbles enables the cell therapy workflow to be run entirely in the sample bag, and the flexibility of microbubbles enables integration into existing systems such as the Cytiva Sepax for cell washing. The ability to isolate cells at large scale with or without automation enables a simple plug-and-play approach across both centralized and decentralized manufacturing models.Methods Apheresis material from multiple donors either underwent upfront processing with Ficoll via the Cytiva Sepax, was cryopreserved then processed, or no pre-processing was completed. All samples then underwent T cell isolation using Akadeum’s Human T Cell Leukopak Isolation Kit, a negative selection kit, via a functionally closed bag system, per manufacturer’s protocol.Results Regardless of how the starting apheresis material was processed, high purity, high viability cells were isolated with the microbubble kit, delivering untouched cells in less time and at a greater scale. Results were repeatable across donors and studies demonstrating that microbubble technology can consistently perform no matter how the starting material has been processed, a critical attribute to provide flexibility in sample processing for manufacturers.Conclusions Akadeum’s instrument-free microbubble isolation eliminates magnetic instrumentation while maintaining high yield/purity. Processing in the sample bag reduces workflow time and cost without compromising expansion capacity or phenotypic integrity. The gentleness of buoyancy combined with a negative selection approach that leaves cells untouched is of benefit to the health of the T cells. This closed-system approach, available in GMP and Clinical Ready grades, supports scalable manufacturing, enabling more doses via higher yields of healthier cells, at any scale and in any cell therapy workflow model.