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.
- 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)
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)