TheraPEAK® LV Nucleocuvette® Cartridge PRO (5 pcs), weldable
TheraPEAK® LV Nucleocuvette® Cartridge PRO (5 pcs), weldable
GMP-grade flow-through reaction vessel supporting the use of the 4D-Nucleofector® LV Unit PRO as manufacturing equipment in a GMP environment. Easily scalable up to 1 billion cells. For use in combination with TheraPEAK® Nucleofector® Solution Sets and TheraPEAK® LV Reservoirs.
Product Overview
Designed for GMP-compliant, large-scale cell engineering
TheraPEAK® LV Nucleofector® Cartridges PRO, used in combination with TheraPEAK® Nucleofector® Solutions and TheraPEAK® 4D-Nucleofector® LV Reservoirs, are specifically designed to support the 4D-Nucleofector® LV Unit PRO as manufacturing equipment in GMP-compliant processes for manufacturing of advanced therapy medicinal products (ATMPs).
Within such manufacturing workflows, the 4D-Nucleofector® LV Unit PRO and its dedicated consumables enable non-viral, electroporation-based genetic modification of primary cells, including T cells and hematopoietic stem cells. Like their research-grade counterparts, TheraPEAK® LV Nucleocuvette® Cartridges PRO serve as the reaction vessels in which the electroporation process is performed — engineered for clinical and commercial manufacturing needs.
GMP-grade manufacturing and quality assurance
TheraPEAK® Nucleocuvette® Cartridges are manufactured in an ISO 7 cleanroom environment at an ISO 13485:2016-certified site. Both manufacturing processes and testing procedures are fully validated, providing confidence for use in regulated GMP settings.
Supporting integration into closed manufacturing workflows
TheraPEAK® LV Nucleofector® Cartridges PRO feature integrated PVC tubing, allowing sterile welding to upstream and downstream process vessels, such as TheraPEAK® LV Reservoirs or cell bags. Alternatively, aseptic connections can be established manually using a Spinning Spiros connector—offering flexibility to match your process design and facility setup.
Comprehensive safety and performance testing
Each TheraPEAK® LV Nucleocuvette® Cartridge PRO is tested according to established standards for:
- Endotoxin (Ph. Eur. 2.6.14)
- Cytotoxicity (EN ISO 10993-5:2009)
- Visible particles (Ph. Eur. 2.9.20)
- Biological performance (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.
Lonza Nucleofector® Units are intended for research use or GMP manufacturing when appropriately qualified, equipped with our 21 CFR part 11 compliant software, and used in combination with our TheraPEAK® Nucleofector® Products.
Benefits
- Single-use, GMP-ready consumables
- Processing volumes up to 20 mL
- Scalable workflows supporting up to 1 billion cells
- Automatic filling via TheraPEAK® 4D-Nucleofector® LV Reservoirs or bags
- Sterile connection to upstream and downstream equipment via welding
- Manufactured from biocompatible material, medical grade (where available)
- Produced in an ISO 7 cleanroom under an ISO 13485:2016-certified quality management system
- Sterilized by a validated ethylene oxide process
- Double-layer packaging to support cleanroom cascades
- Validated manufacturing and testing methods
- License-fee free commercial use
Applications
- Large-scale genome editing for transient (mRNA, DNA) or stable (CRISPR-based knock-out or knock-in, transposon-based integration) applications
- Enabling GMP-compliant manufacturing with the 4D-Nucleofector® LV Unit PRO
Storage and Content
5 TheraPEAK® LV Nucleocuvette® Cartridges PRO, weldable tubing
SDS, CoA, and Instructions
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.