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

Name: TheraPEAK ® 4D-Nucleofector ® LV Reservoirs, weldable (5 pcs)
Brand: Lonza

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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)

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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

Brochures, White Papers etc.

Videos

Large-volume Non-viral Genetic Modification in Cell and Gene Therapy
Discover this white paper and learn how researchers are using the 4D-Nucleofector® LV Unit in cell and gene therapy development and manufacturing.

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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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