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

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
 

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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)

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SDS, CoA, and Instructions

Safety Data Sheets (SDS)

Choose a language to view the SDS.

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.

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Educational Material

Videos

  • 4D-Nucleofector® LV Unit for Cell and Gene Therapy Applications – Benefits and How it Works

    From this video learn how it works and its benefits for cell and gene therapy manufacturing.
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Non-viral Methods for Ex Vivo Cell and Gene Therapy: Is the Future
Non-viral?

Podcast

Listen in as our experts discuss the types and benefits of non-viral methods for ex vivo cell and gene therapy as well as the readiness of electroporation-based technologies for use in GMP manufacturing.

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