Title: Revolutionising large-scale MSC manufacturing: 3D FloTrix technology with dissolvable microcarriers and automation for the future of cell therapy
Abstract:
CytoNiche has developed 3D RecomTrix recombinant collagen dissolvable microcarriers for large-scale manufacturing of adherent cells, critical for allogeneic cell therapies like Mesenchymal Stem Cells (MSCs) and cell-free therapies like exosomes. The 3D FloTrix Technology integrates these microcarriers into automated, closed single use bioreactors and cell processing systems to address scalability and purification challenges in cell therapy production. Over 100 billion MSCs could be produced in a single batch with 3D RecomTrix recombinant collagen microcarriers using serum-free xeno-free cell culture medium in a three-stage scale up to 4 X 50L single-use bioreactors. Cells could be washed, concentrated, and formulated with 3D FloTrix vivaPREP ULTRA and automatically filled and finished. 3D FloTrix has powered the first approved MSC drug in China in achieving industrial-scale cell yields with a 3-stage process, compacted facility footprint (<100 m²), and 80% reduction in workforce. CytoNiche aims to advance cell therapy manufacturing by offering a scalable, cost-effective solution that improves product quality and accessibility, benefiting sectors from regenerative medicine to vaccine production. This technology addresses critical bottlenecks in adherent cell processing, positioning it as a versatile tool for sustainable biopharmaceutical innovation.
