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Cell Therapy Kits and Assemblies

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Support closed, sterile cell therapy workflows

Cell therapy manufacturing demands tightly controlled, closed-system liquid handling across T cell isolation, processing, storage, and transfer steps. Open processing steps can introduce the risk of microbial contamination, loss of cell viability, and batch failure that can compromise program timelines.

 

CTS single-use kit assemblies are designed to integrate directly with automated CTS instruments and support cGMP-compliant manufacturing environments. Unlike general-purpose bags, CTS kit assemblies specifically support T cell workflows by reducing manual interventions and enabling contamination control within an integrated workflow.

Benefits of cell therapy kits and assemblies

Cell therapy kits and assemblies offer performance and quality advantages compared to open or non-integrated alternatives.

Contamination control

  • Closed-system design helps limit open liquid handling steps
  • Reduces opportunities for microbial ingress during T cell isolation and processing
  • Minimizes manual handling of the cell suspension


     

Regulatory support

  • Manufactured under ISO 13485-certified quality systems
  • Regulatory support files (RSFs) are available upon request
  • Documentation includes extractables and leachable data, biocompatibility testing, and gamma sterilization verification

Process continuity

  • Assembly formats are available in configurations suited for small-scale process development and cGMP manufacturing
  • Consistent assembly formats across scales can help maintain process consistency
  • Reduces requalification burden during scale-up

Cell therapy kits and assemblies across manufacturing stages

Kit assemblies with bags are used across multiple stages of the T cell manufacturing workflow. The assemblies support upstream processing (USP), including initial cell isolation from leukapheresis or whole blood material, as well as subsequent steps such as magnetic bead removal. Consistent use of compatible single-use assemblies across stages can help reduce variability between steps.

T cell isolation and activation

Support the isolation of T cells from starting material using bead-based magnetic separation in a closed format with single-use kit assemblies. 

 

Designed for use with the Gibco CTS DynaCellect Magnetic Separation System, the Gibco CTS DynaCellect Cell Isolation Kit is a single-use, fit-for-purpose kit used for isolation and activation of immune cells in cell processing applications. The kit features eight weldable lines with DEHP-free PVC tubing and accommodates working volumes up to 1 L.

 

Magnetic bead removal

Magnetic beads used during separation and activation must be removed before downstream processing (DSP) and final formulation. An integrated bead removal step can help maintain product quality, generate reliable characterization data, and support processes that align with regulatory requirements.

 

The Gibco CTS DynaCellect Bead Removal Kit enables closed-system bead removal after T cell isolation. Single-use assemblies include gamma-sterilized construction and 0.20 µm sterile air filters to help maintain sterility while reducing manual handling of the cell suspension.

 

Ordering information

货号 产品名称 规格 Price 数量
A52300 CTS™ DynaCellect™ Cell Isolation Kit Each
53,199.50
A52301 CTS™ DynaCellect™ Bead Removal Kit Each
53,199.50

Enhance workflows with cell therapy solutions

Cell therapy products can help teams reduce open handling steps, maintain process consistency, and build toward a cGMP-ready manufacturing platform.

CTS DynaCellect Magnetic Separation System

An automated, closed system for bead-based T cell isolation and bead removal, directly compatible with kit assemblies. Designed for Class C cleanroom environments with OPC-UA connectivity and support for 21 CFR Part 11-compliant data handling with system upgrade.

CTS Rotea Counterflow Centrifugation System

The Gibco CTS Rotea Counterflow Centrifugation System is a closed system for volume reduction, washing, and concentration of cell therapy products. Compatible with single-use processing sets, it enhances downstream cell processing within an integrated T cell manufacturing workflow.

Frequently asked questions

The CTS DynaCellect Cell Isolation Kit and CTS DynaCellect Bead Removal Kit are single-use assemblies designed for use with the CTS DynaCellect Magnetic Separation System. The CTS DynaCellect Cell Isolation Kit features eight weldable lines with DEHP-free PVC connections, while the CTS DynaCellect Bead Removal Kit includes four weldable lines configured for downstream bead detachment and removal steps. Both kits are gamma-sterilized and designed to integrate with the system’s closed fluidic path.

Cell therapy kits and assemblies are gamma-sterilized and shipped ready to use. This construction supports closed processing requirements by removing the need for in-house sterilization steps prior to use. Gamma sterilization verification data is available in the RSF package and can be requested.

The CTS DynaCellect Cell Isolation Kit features a maximum capacity of 1 L with eight weldable lines and DEHP-free PVC connections (150 mm, 2.4 mm ID, and 4.0 mm OD). The CTS DynaCellect Bead Removal Kit allows for continuous processing with four weldable lines and the same PVC connection specifications. For custom configurations, contact us to speak with a specialist.

RSFs are available for kits and assemblies and include extractables and leachable data, biocompatibility testing, and gamma sterilization verification. These documents are designed to support IND, BLA, and other regulatory filings. RSF packages can be requested. These are intended to facilitate the documentation review process during manufacturing authorization and regulatory submission activities.

Discover cell therapy bioprocessing solutions

Explore cell therapy bioprocessing solutions that help maintain consistency as programs progress from development to manufacturing and adapt to autologous or allogeneic needs.

Cell therapy resources

Access application notes, white papers, and technical references relevant to T cell manufacturing, process development, and cGMP compliance. These materials are intended to support decision-making and process optimization across manufacturing stages.

Maintain containment throughout cell therapy workflows

For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.