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Pharma & Biotech

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.

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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 

Content & Storage

Content

 5 TheraPEAK® 4D-Nucleofector® LV Reservoirs (weldable tubing)

Safety Data Sheets (SDS)

Certificate of Analysis (CoA)

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