Description
Product Overview TheraPEAK® Nucleofector® Consumables are aimed to support the use of the 4D-Nucleofector® LV Unit as manufacturing equipment in a GMP manufacturing process for advanced therapeutic medicinal products (ATMPs). In such a process, the 4D-Nucleofector® LV Unit and its consumables may be used for non-viral, electroporation-based genetic modification of primary cells, for example T cells or hematopoietic stem cells. Like their research-grade counterparts, TheraPEAK® 4D-Nucleofector® LV Reservoirs are the Lonza designed vessels for transferring the cell suspension sample into a TheraPEAK® LV Nucleocuvette® Cartridge and to collect the sample after transfection. In contrast to the research-grade LV Reservoir, the TheraPEAK® LV Reservoirs come with a new design: Injection-molded body and cap glued together to provide a fully closed environment Lower PVC tubing allows for sterile welding to a TheraPEAK® LV Nucleocuvette® Cartridge (input line) or downstream equipment (output line) Upper PVC tubing enables filling from top either from upstream equipment (sample input) or TheraPEAK® LV Nucleocuvette® Cartridge (transfer of transfected sample into collection reservoir) Sterile welding: The PVC tubing allows for sterile welding to a TheraPEAK® LV Nucleocuvette® Cartridge or upstream/downstream equipment. Alternatively, sterile connections can be established manually via Luer connectors. TheraPEAK® 4D-Nucleofector® LV Reservoirs are tested for • Endotoxin (Ph. Eur. 2.6.14) • Cytotoxicity (EN ISO 10993-5:2009) • Visible particles (Ph. Eur. 2.9.20) • Sub-visible particles (Ph. Eur. 2.9.19) • Biology (Nucleofection® Experiment) Disclaimer: TheraPEAK® Nucleofector® Products are produced according to applicable GMP standards and are intended to support GMP manufacturing. TheraPEAK® Nucleofector® Cartridges and Reservoirs are produced at manufacturing sites with an ISO13485 certified quality management system. TheraPEAK® Nucleofector® Products are not intended for in vivo and/or diagnostic purposes Request More Info
Benefits Single-use consumables Use of biocompatible material, medical grade (where available) Produced at an ISO13485:2016 certified site in a class C environment Sterilized by ethylene oxide (validated process) Double-layer packaging supporting the clean room cascade Validated manufacturing and testing methods Applications Supporting use of 4D-Nucleofector® LV Unit in GMP manufacturing
Storage and Content 5 TheraPEAK® 4D-Nucleofector® LV Reservoirs (weldable tubing)
