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4D-Nucleofector® LV Unit PRO

4D-Nucleofector® LV Unit PRO

Catalog #: AAF-1003L

Next generation large-scale Nucleofector® Platform for closed, scalable transfection of up to 1 billion cells – from research to GMP manufacturing

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Product Overview

Large-scale transfection using the 4D-Nucleofector® LV Unit PRO - experience the next generation 4D-Nucleofector® LV Unit PRO which comes with several new features and can be easily implemented into a GMP manufacturing process:

  • Optimized cartridge design for improved performance for CRISPR-based knock-out/in or transposition
  • Fixed-volume cartridge with different filling volumes between 0.5 and 2 mL and new port for easy loading and clearing
  • Flow-through cartridge with more robust sample processing
  • Cartridge insertion support and visual acknowledgement

Like its predecessor, the first generation 4D-Nucleofector® LV Unit, the LV Unit PRO comes with two cartridge types:

The fixed-volume cartridge is suited for different filling volumes (0.5 mL, 1 mL, 1.5 mL and 2 mL). This can be manually loaded with sample via an injection port using a pipette.

The flow-through cartridge with flexible volumes up to 20 mL is automatically filled via our 4D-Nucleofector® LV Reservoirs (or bags). The cartridge is equipped with PVC tubing which can be connected to upstream and downstream equipment via manual Luer connection (during early process development) or sterile welding (for GMP manufacturing). 

Both are available as research-grade and GMP-grade version (GMP planned for Q4-2025) and are used in combination with the corresponding research-grade or GMP-grade P3 Primary Cell Nucleofector® Solution LV Sets.

Transfection protocols can be established in smaller scale using the 4D-Nucleofector® X Unit and subsequently transferred to the LV Unit PRO with only a small re-optimization in 500 μL volume.

Use as manufacturing equipment in a GMP environment - accompanied by GMP grade TheraPEAK® Consumables (planned for Q4-2025), a 21CFR part 11 compliant software and IQOQ services, the LV Unit PRO is suited to quickly translate research results into a GMP compliant manufacturing process.

Cell type-specific Optimized Protocols or recommendations available in our knowledge database. In these Optimized Protocols the best Nucleofection® Conditions are indicated. In addition, we share our experience and knowledge for treatment of individual cell types. If you do not find recommendations for your cell type of interest, please contact our Scientific Support Team.

Technical specifications

Dimensions: (w x h x d): 24.5×20.7×28 cm / 9.7×4.1×11.0
Weight: 6.1 kg (12.5 lb)
Power: 100 - 240 VAC
Frequency: 50 - 60 Hz
Consumption: 0 VA (power off) / 20 VA (idle) / 140 VA (busy - during transfection)
Fuse: T 2.5A, L250V
Operating temperature: +15°C up to +40°C (59°F - 104°F) non-condensing
Environment non condensing voltage limitation: 1500 V
Current limitation: 100 A

Quality statement:

We are applying ISO 9001:2015 standards for the design, manufacturing and testing of Nucleofector® Devices since 2004.

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.

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Benefits

  • Reliable, robust and efficient delivery of complex, clinically relevant cargos
  • Easy scale up of the cell engineering process for up to 1 billion T cells
  • Two vessel formats for closed transfection of medium or larger cell numbers
  • Performance proven for resting and activated T cells
  • Corresponding research-grade and GMP-grade consumables to transfer process development into GMP manufacturing
  • 4D-Nucleofector® LogWare for operation under 21 CFR part11 compliant software
  • Highly-skilled technical support
  • Training support and IQOQ service

Applications

  • Ex-vivo modification of human primary cells for cell therapy applications (e.g. genome editing, generation of CAR-T cells)
  • Suited for research, process development and GMP manufacturing

Storage and Content

1 unit

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SDS, CoA, and Instructions

Safety Data Sheets (SDS)

SDS not applicable

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.

  • Nucleofector® Technology Brochure

    Stretching Transfection Dimensions
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Educational Material

Brochures, White Papers etc.

  • Non-viral delivery of complex cargos for large-scale T cell manufacturing

    Discover how the new 4D-Nucleofector® LV Unit PRO and the Nucleocuvette® Cartridge PRO support reliable, robust and efficient delivery of complex, clinically relevant cargos
  • 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.
  • 4D-Nucleofector® LV Unit PRO

    Next-generation large-scale electroporation from research to GMP manufacturing
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Data

Scalability for transient cargos

Transfection efficiency for the LV PRO FV and FT cartridge compared to the small scale 20 µL and to the 100 µL reference. A low cargo dose was delivered: (A) 20 µg/mL EGFP mRNA and (B) 12 µg/mL pmaxGFP™ Vector (3.4 kb). Cells were electroporated at 5.0 x 107 cells/mL. Viability (DAPI staining) was 90% on time point of analysis, 24 h after transfection.

Data

Scalability and robustness with various genome editing approaches

(A) KO efficiency for the LV PRO FV vs small scale 100 µL reference and first-generation LV FV (2 donor, 4 technical replicates). (B) Representative KI efficiency for the LV PRO FV and LV PRO FT cartridges compared to the small scale 100 µL reference (1 donor, 4 technical replicates). (C) KI data from 7 healthy donors and 13 different experiments were normalized versus the 100 µL reference (set at 100%) to account for donor variability. The graphs show KI efficiency and number of viable edited cells with two electric programs. The performances of the first-generation LV FV cartridge are included for comparison. The cargo system delivered was Cas9 RNP and ds DNA HDR template, 1.4 kb (RAB11A-GFP).

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Large scale editing of human T cells

Webinar
Learn about how the new Nucleofector® Platform is used for large scale editing with CRISPR and the TcBuster™ transposon system.

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.