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TheraPEAK® LV Nucleocuvette® Cartridge, weldable (5 pcs)

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TheraPEAK® LV Nucleocuvette® Cartridge (5 pcs), weldable

Containing 5 TheraPEAK® LV Nucleocuvette® Cartridges with weldable tubing

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.

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Product Overview

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
 

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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® LV Nucleocuvette® Cartridges, weldable tubing

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Non-viral Methods for Ex Vivo Cell and Gene Therapy: Is the Future
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