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TheraPEAK® LV Nucleocuvette® Cartridge, weldable (5 pcs)
TheraPEAK® LV Nucleocuvette® Cartridge, weldable (5 pcs)
Catalog #: G4LN-7520W
For use in combination with TheraPEAK® Nucleofector® Solution Sets, supporting the use of the 4D-Nucleofector® LV Unit in a GMP environment.
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® LV Nucleocuvette® Cartridges are the reaction vessels in which the electroporation process takes place. They are used in combination with TheraPEAK® Nucleofector® Solutions and TheraPEAK® 4D-Nucleofector® LV Reservoirs.
Sterile welding:
The PVC tubing extension which is attached to the silicone tubing allows for sterile welding to a TheraPEAK® Nucleofector® LV Reservoir or a bag. Alternatively sterile connections can be established manually via a Spinning Spiros connector.
TheraPEAK® LV Nucleocuvette® Cartridges 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)
• Extractables (during validation)
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
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® LV Nucleocuvette® Cartridges, weldable tubing
SDS, CoA, and Instructions
Certificate of Analysis (CoA)
Please enter Lot Number, including all zeros, located on the product label and please take into account that it is case sensitive.
