Consumables and software

The Xenon Electroporation System is designed for superior non-viral transfection performance, ease of use, and a closed, integrated workflow. Two compatible electroporation configurations allow seamless scaling from process development to commercial manufacturing.


1 mL SingleShot electroporation chamber

The SingleShot chamber, designed for process development, can transfect 2–10 x 10⁷ cells in one batch.

Specifications

Note: Instrument and Consumable Regulatory Support File available upon request at thermofisher.com/regulatory.

Ordering information for SingleShot electroporation chamber

For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products.


5–25 mL MultiShot electroporation cartridge

The single-use MultiShot flow-through cartridge can transfect 0.1–2.5 x 10⁹ cells in a continuous process, 1 mL at a time. Its cartridge format with pre-routed tubing enables efficient and worry-free loading, while setup cues and the software interface confirm correct installation.

Specifications

Ordering information for MultiShot electroporation cartridge

A53445: For Research Use Only. Not for use in diagnostic procedures.
A50306 (subject to availability): For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products.


Electroporation buffers

We offer two different buffers designed for use with the Xenon Electroporation System. Gibco CTS Xenon Electroporation Buffer is a universal buffer that supports the transfection of a variety of human primary cells and payloads (such as plasmid DNA, mRNA, miRNA, or siRNA) for gene up-regulation or down-regulation applications. Gibco CTS Xenon Genome Editing Buffer is designed specifically to improve performance with gene editing-specific payloads (such as CRISPR-Cas9) for knock-out or knock-in applications in a variety of human primary cells.

 

 

Both Xenon buffers are phosphate- and salt-based and contain ions and sugars to control for conductivity and osmolality.

Closed-system compatibility. Both Xenon buffers are available in 100-mL bottle and 100-mL bag formats for convenient process development and closed-system manufacturing scale-up.

 

CTS quality. Gibco CTS products follow USP <1043> covering “ancillary materials for cell, gene, and tissue-engineered products” within the responsibilities applicable to a supplier.* The products are supplied with harmonized documentation such as intended use statements, certificates of analysis, and certificates of origin. Regulatory support, such as letters of authorization to reference our drug master file (DMF), are available to assist in your regulatory filing.

 

Gibco CTS products are of high quality and are manufactured at a site that uses methods and controls that conform to cGMP for medical devices, 21 CFR Part 820 and Ph Eur 5.2.12. Our FDA-registered manufacturing sites are ISO 13485-certified.

Ordering information for electroporation buffers

*Other aspects of USP <1043> will be the responsibility of the customer to assess. Thermo Fisher Scientific cannot fulfill application and therapy-specific aspects of USP <1043> such as residual assessment and removal of the ancillary materials.

 

For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.


Bioprocess automation and control software

In cell and gene therapy, “the process is the product,” so perhaps the primary challenges are issues of manufacturing. Autologous T cell therapy, for example, often includes many open processes that are prone to contamination, and many labor-intensive manual manipulations that are prone to errors. Solutions to the first challenge include moving to a closed system, while solutions to the second include automation.

 

As explained in Features, the Xenon Electroporation System can be physically integrated with other Thermo Fisher Scientific instruments and consumables, such as the CTS Rotea Counterflow Centrifugation System and the HyPerforma Rocker Bioreactor, into a complete, closed cell therapy manufacturing workflow.

In addition, these instruments are all digitally connectible with full Open Platform Communications–Unified Architecture (OPC-UA) compatibility. They are designed to be automated and controlled by bioprocess controllers and software compatible with the Emerson’s DeltaV™ Distributed Control Platform, a widely used, well accepted, open system that conveys seamless connectivity to all layers of automation.

 

Digital integration is especially important when moving from research and process development to GMP manufacturing. Thermo Scientific TruBio Bioprocess Automation and Control Software, powered by the DeltaV Discovery platform at lab scale and the DeltaV platform at pilot, clinical, and production scales, facilitates easy integration of multiple instruments and processes to streamline process control and data management from research to commercial applications.

 

Data quality, integrity, and traceability are key to meeting regulatory requirements. Our modules and software all support secure, repeatable data flow between the equipment and your data management systems.


Intended use of the products mentioned on this page varies. For specific intended use statements, please refer to the product label.