Added to Your Shopping Cart
Certificate of Analysis
Are you looking for...
You might be interested in...
Type in Product name, Keyword or Catalog number to see suggestions.
Looking for a Certificate of Analysis?
Have your catalog and lot numbers ready and click the link.
Find CoA
Need help? Please contact us
TheraPEAK® 4D-Nucleofector® LV Reservoirs, weldable (5 pcs)
1
of
TheraPEAK® 4D-Nucleofector® LV Reservoirs, weldable (5 pcs)
Catalog #: G4LR-1501W
For use in combination with TheraPEAK® Nucleocuvette® Cartridges, 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® 4D-Nucleofector® LV Reservoirs are the Lonza designed vessels for transferring the cell suspension sample into a TheraPEAK® LV Nucleocuvette® Cartridges 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
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)
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.
