NANT Systems automated technology enhance your manufacturing performance.

NANT Systems have been validated under conditions fully compliant with Good Manufacturing Practice (GMP) by a third-party institution licensed for the manufacture of cell therapy products, and are suitable for use in GMP Grade D cleanrooms.

How We Help You to Be cGMP-Compliant

Single Use

Single-use disposables designed to ensure aseptic processing, to avoid cross-contamination and mix-ups of materials. §17.21 §9.35 §9.31

Aseptic Connectors and Disconnectors

An easy and quick solution suitable for use in Grade D environment. No welding is needed! §5.13 §9.44

Safe Sampling

Thanks to the one-way valves integrated on all Cartridge components, reagents and intermediate products sampling is always possible while ensuring aseptic processing. §12.25

Continuous and Remote Monitoring of Key Process Parameters

The expansion process and all the key parameters can be checked remotely in real-time thanks to the dedicated web application. Users can monitor the culture progress from any device (smartphone, laptop, tablet) without accessing the cleanroom. §9.70

Full Process Traceability

The integrated barcode reader allows the identification of Cartridge components and Users actively involved in the manufacturing operations. All critical operations, warnings and alarms are recorded and tracked. §6.39 §17.22

Downloadable Cell Culture Report

The Cell Culture Report is a fully automated recording of all events occurred during the expansion process. The information is provided in a downloadable PDF format that can be easily integrated in any QMS as an auditable document while all the raw data are also available (downloadable LOG file). §6.26 §9.70 §17.22

§* Chapters of the Guidelines on GMP specific to ATMPs – EudraLex Vol.4 /GMP.