4D-Nucleofector^® LV Unit – Large volume transfection for ex vivo cell and gene therapy

Expedite your translational path and experience the LV Unit which expands our proven 4D-Nucleofector® System to large-scale transfection. It allows for closed, scalable transfection of human primary cells, e.g. human T cells, in the range of 1x10⁷ to 1x10⁹ cells. Transfection protocols can be established in smaller scale using the 4D-Nucleofector® X Unit and subsequently transferred to the LV Unit without the need for extensive re-optimization. GMP grade TheraPEAK® Consumables, a 21CFR part 11 compliant software and IQOQ services allow you to quickly translate research results into a GMP compliant cell therapy manufacturing process.

Benefit from:

• Closed system: Sterile transfection of up to 10⁹ cells
• Real scalability: Optimization in small scale
• Established protocols: Benefit from 700+ optimized cell types
• Simple handling: Minimal training needs
• 4D-Nucleofector® LogWare: Optional operation via 21CFR part11 compliant software
• Fit for purpose: consumables for research use and GMP manufacturing*

Applications:

• Efficient transfection of human primary blood cells, e.g. T cells or NK cells
• CRISPR genome editing using plasmid, mRNA or RNPs
• CAR-T cell generation using transposon-based systems or mRNA

Formats Available

Large-Scale Transfection

Selected Publications – Pre-Clinical Research

• Woodruff et al. (2023) Large-scale manufacturing of base-edited chimeric antigen receptor T-cells. Mol Ther Methods Clin Dev 31:101123
• Nawandar et al. (2022) Human anelloviruses produced by recombinant expression of synthetic genomes. bioRxiv preprint
• Vazquez-Lombardi et al. (2022) High-throughput T cell receptor engineering by functional screening identifies candidates with enhanced potency and specificity. Immunity 55:1953–1966
• Georgiadis et al (2021) Base-edited CAR T Cells for combinational therapy against T cell malignancies. Leukemia 35(12):3466-3481
• Lattanzi et al. (2021) Development of β-globin gene correction in human hematopoietic stem cells as a potential durable treatment for sickle cell disease. Science Translational Vol. 13, Issue 59
• Basar et al. (2020) Large-scale GMP-compliant CRISPR-Cas9–mediated deletion of the glucocorticoid receptor in multivirus-specific T cells. Blood Adv 4(14): 3357–3367
• Brownrigg et al. (2020) Closed-system transposon-mediated manufacture of GMP grade CAR T-cells via the Lonza Nucleofector LV XL. Cytotherapy 22: S382
• Mendt et al. (2018) Generation and testing of clinical-grade exosomes for pancreatic cancer. JCI Insight 3(8) [Epub ahead of print]
• Schiroli et al. (2017) Preclinical modeling highlights the therapeutic potential of hematopoietic stem cell gene editing for correction of SCID-X1. Sci Transl Med 9(411):eaan0820
• Dever et al. (2016) CRISPR/Cas9 β-globin gene targeting in human haematopoietic stem cells. Nature.539(7629):384-389

Selected Publications – Clinical Studies

• Chiesa et al. (2023) Base-Edited CAR7 T Cells for Relapsed T-Cell Acute Lymphoblastic Leukemia. N Engl J Med 389(10):899-910
• Ottoviano et al. (2022) Phase 1 clinical trial of CRISPR-engineered CAR19 universal T cells for treatment of children with refractory B cell leukemia. Sci. Transl. Med. 14, eabq3010

Selected Publications – Clinical Studies (Other Units)

Would you like to learn more?

Discuss your needs with our transfection specialists.

*TheraPEAK^® Nucleofector^® Products are produced according to applicable GMP raw material standards and are intended to support GMP manufacturing. TheraPEAK^® Nucleofector^® Solutions are manufactured at a GMP certified site. 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. All other Nucleofector^® Products are for research use only.