Cell growth factor Xuri IL-21 regulates human natural killer (NK) and cytotoxic T cells. It follows USP for cell therapy ancillary material.
Minimized process development time.
Improved scale-out capacity.
Reproducible performance without revalidation of each lot.
Dedicated cell therapy ancillary product following USP for ex vivo cultivation.
Rapid and dependable process development for cell therapy manufacturing
Each lot of Xuri IL-21 includes clear information on biological activity to improve control over cultivation variability. This information enables standardization of the process to deliver reproducible cell expansion without the need for revalidation of each new lot.
USP <1043> compliance
A smooth submission process is key when dealing with cell therapy regulatory requirements. To help users assess and document production processes, Cytiva supplies Xuri IL-21 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.
End user responsibility
Other aspects of USP <1043> will be the responsibility of the end user to assess. Cytiva cannot fulfill USP <1043> in regard 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.
Long-standing experience
Cytiva, 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.
