CTS Xenon Electroporation System Accessories

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

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

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

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.

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

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

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.

*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.

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.