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

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

Catalog #: G4LR-1501W

Please email us at cs@medikonia.com for any enquiry. To place an order, please include the catalog number(s) of the product(s) in the email.