Xuri IL-2

Reliable activation of T-lymphocytes for efficient cell expansion. Follows USP <1043> for cell therapy ancillary material.

• Minimized process development time.
• Improved scale-out capacity.
• Reproducibility without revalidation.
• Proven technology in Xuri Cell Expansion System.
• Dedicated cell therapy ancillary product following USP <1043> for ex vivo cultivation.

Rapid and Dependable Process Development for Cell Therapy Manufacturing

Xuri IL-2 is a reliable solution for the expansion of T-lymphocytes. Xuri IL-2 is provided with information on biological activity, which improves reproducibility and removes the need for revalidation.

Building on our experience in this application, we supply Xuri IL-2 together with detailed protocols for efficient expansion of T cells in Xuri Cell Expansion Systems.

USP <1043> Compliance

A smooth submission process is key when dealing with cell therapy regulatory requirements. To help our users assess and document their production processes, we supply Xuri IL-2 products with a comprehensive documentation support package that meets USP <1043> ‘ancillary materials for cell, gene, and tissue-engineered products’, within the responsibilities applicable to a supplier. Other aspects of USP <1043> will be the responsibility of the end-user to assess. GE Healthcare cannot fulfill USP <1043> in regards to application and therapy specific aspects (e.g. use in finished therapeutic, assessment of removal from a finished therapeutic and possible biocompatibility, cytotoxicity or adventitious agent testing). No human components are included in the product.

GE Healthcare, a well-established supplier to the clinical and pharmaceutical market worldwide, now brings its long-standing experience in regulatory requirements to the field of Cell Therapy manufacturing.