Closed-system compatibility
CTS Xenon Electroporation Buffer is available in 100-mL bottle and 100-mL bag formats for convenient process development and closed-system manufacturing scale-up.

CTS quality
Gibco CTS products follow USP <1043> 'ancillary materials for cell, gene, and tissue-engineered products' within the responsibilities applicable to a supplier.&ast; The products are supplied with harmonized documentation such as intended use statements, certificates of analysis, certificates of origin, and convenient access to our drug master file (DMF). Full documentation traceability is available to support your regulatory filing.

Gibco CTS products are manufactured at a site that uses methods and controls that conform to cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing sites are ISO 13485-certified.

&ast;Other aspects of USP <1043> will be the responsibility of the end user to assess. Thermo Fisher Scientific cannot fulfill USP <1043> in regard to application and therapy-specific aspects (eg, residual assessment and removal of the AM).