GE Healthcare Launches Xuri™ IL-2 Growth Factor
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Xuri™ IL-2 is a dedicated cell therapy ancillary product for the ex vivo cultivation of T-lymphocytes. Xuri IL-2’s defined level of biological activity removes the need for revalidation of each lot and strongly improves reproducibility, thereby minimizing process development time and improving scale out capacity.
Xuri IL-2 features low endotoxin levels (<0.025 EU/µg), is produced under a GMP license certified and regularly audited, quality controlled under ISO9001:2008 and in accordance with the International Conference on Harmonization (ICH) guideline.
Xuri IL-2 is supplied with comprehensive instructions for straightforward expansion in static culture and with the Xuri Cell Expansion Systems W5 and W25.
Also now available is IL-2 for preclinical use, a cost efficient alternative for the cultivation of T-lymphocytes in proof-of-principle and basic research experiments.
The close equivalence between IL-2 and Xuri IL-2 simplifies the transition from research to process development for cell therapy manufacturing with minimized optimization time while supporting regulatory compliance.
Xuri products are supplied with a comprehensive documentation support package that follows USP <1043> requirements applicable to a supplier of ancillary material for cell, gene and tissue-engineered products to enable a full assessment and documentation of the production processes. This contributes significantly to facilitating risk assessment and validation in cell therapy manufacturing.