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Consumables

The CTS Xenon Electroporation System is designed to be an easy-to-use system for exceptional, nonviral transfection performance which supports a closed, integrated workflow. Two compatible electroporation accessories allow scaling from process development to commercial manufacturing.


CTS Xenon 1 mL SingleShot electroporation chamber

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

Electroporation chamber specifications

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

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

CTS Xenon 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.

Electroporation cartridge specifications

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

Order CTS Xenon MultiShot electroporation cartridges

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

Electroporation buffers

We offer three 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. It is also conveniently available as a kit with Gibco CTS HiFi Cas9 Protein to provide 2X improved knock-in efficiency. Gibco CTS Xenon Lower Conductivity Electroporation Buffer is designed for use with cell types that require higher energy electroporation settings to achieve successful transfection.

 

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

 

Closed-system compatibility. CTS 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.

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*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.


CTS Cas9 proteins

We offer two different Gibco CTS Cas9 proteins designed to support clinical research and applications that require Cas9 nuclease manufactured to stringent specifications. Gibco CTS HiFi Cas9 Protein is a high-fidelity Cas9 protein designed to significantly reduce off-target events in a broad range of cell types while maintaining high on-target editing efficiency. It is also conveniently available as a kit with the CTS Xenon Genome Editing Buffer to provide 2X improved knock-in efficiency. Gibco CTS TrueCut Cas9 Protein is a wild-type Cas9 protein designed to deliver maximum CRISPR editing efficiency.

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Bioprocess automation and control software: Integration of the Xenon system with other Thermo Fisher Scientific products

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 CTS DynaCellect Magnetic Separation System, 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. Gibco CTS Cellmation software is an off-the-shelf solution designed to help simplify and optimize cell therapy manufacturing processes by providing digital connectivity to Thermo Fisher Scientific’s modular cell therapy instrumentation while enabling 21 CFR Part 11 compliance. 


Gibco PeproGMP Growth Factors and Cytokines

Thermo Fisher Scientific offers GMP recombinant proteins that can help you seamlessly scale your cell production process while meeting clinical requirements. Gibco PeproGMP cytokines are designed and manufactured to support end-to-end manufacturing of cell therapies and other biotherapeutics.

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