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-15 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.

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.