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

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^® LV Nucleocuvette^® Cartridges, weldable tubing

Catalog #: G4LN-7520W

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.