KNOWLEDGE CENTER
Advancing Cell Therapy Manufacturing:
Transitioning from process development to clinical and commercial-scale manufacturing requires a robust, functionally closed ecosystem. Rhenium Bio delivers the complete Thermo Fisher Scientific Cell Therapy Systems (CTS™) portfolio.
What is CTS™? Gibco™ Cell Therapy Systems (CTS™) are a comprehensive ecosystem of GMP-manufactured media, reagents, and instruments. Designed specifically for cell and gene therapy manufacturing, they provide the high standards of safety, quality, and regulatory documentation (including DMFs) required to facilitate clinical translation and commercial success.
Integrated Instrumentation
Standardizing cell therapy manufacturing is a multi-stage challenge. By adopting a Closed and Automated Workflow, organizations can bridge the gap between process development and GMP production. Our modular instruments are designed to operate as a single, sterile ecosystem, significantly lowering cleanroom classification requirements and eliminating manual variability.
Isolation & Activation
Magnetic bead–based technology for automated cell isolation and activation in a closed environment. Highly efficient bead removal ensures maximum product purity.
Cell Engineering
Viral vector production solutions and large-scale electroporation. Seamless support for advanced CRISPR and TALEN gene editing tools at clinical scale.
Cell Processing & Wash
Gentle cell washing, concentration, and buffer exchange. Maintains high viability while automating manual centrifugation steps in a sterile loop.
Formulation & Fill-Finish
Closing the workflow loop with automated formulation and high-precision dosing. Integrated with cryopreservation reagents and controlled-rate freezing solutions.
World-class instrumentation is only effective when supported by a standardized biological foundation. The Gibco™ CTS™ Media and Reagents portfolio provides the required consistency for clinical success. Every product is manufactured under GMP conditions and includes comprehensive documentation to simplify your transition from development to commercial manufacturing.
- Gibco™ CTS™ Buffers
- Gibco™ CTS™ TrypLE™ Select
- Gibco™ CTS™ ACK Lysing Buffer
- Gibco™ CTS™ HBSS (1X)
- Gibco™ CTS™ DPBS (without Ca/Mg)
- Gibco™ CTS™ Dynabeads™
- Gibco™ CTS™ TrueCut™ Cas9
- Gibco™ CTS™ HiFi Cas9 Protein
- CTS™ Viral Production Systems
- Specialized AAV / Lentivirus kits
- CTS™ Media for Immune cells
- Media for Hematopoietic cells
- Media for Neural/Pluripotent cells
- Gibco™ CTS™ Supplements
- Gibco™ CTS™ TrypLE™ Select
- Gibco™ CTS™ Wash Reagents
- Gibco™ CTS™ Cryopreservation Reagents
- Specialized GMP Buffers
Proven Excellence: Performance Evaluation Study
Scientific Analysis of Integrated Workflow Performance in Primary T Cells
Key Scientific Conclusions
Volumetric Precision & Scaling
The study validated that the integrated CTS Rotea and CTS Compleo workflow maintains absolute volumetric accuracy (1.96 mL result for 2.0 mL target) even when scaling from 1L to 20L input volumes. Automation successfully eliminated the variability typically found in manual large-scale manufacturing.
Maintaining High-Value Biology
Primary T cells processed through the automated loop demonstrated exceptional quality retention. High cell recovery (average 99%) and sustained viability (>96.5%) prove that mechanical processing does not compromise the therapeutic integrity of the final product.
Batch Homogeneity & Dosing Consistency
A critical finding was the consistent cell concentration across all 10 dosing lines. The integrated paddle mixing logic in the Compleo system ensures that every dose provided to a patient is uniform, regardless of its position in the dosing sequence.
Risk Mitigation & Time Efficiency
Total formulation and filling time was reduced from a manual average of 45 minutes to just 15 minutes. This 66% reduction in “hands-on” time directly translates to a lower risk of operator-induced error and minimized exposure of the active ingredient to room temperature.
Expert Application Support in Israel
Rhenium Bio Science provides the technical and clinical foundation for your success in Israel. From workflow design and custom protocol development to comprehensive IQ/OQ qualification services, our dedicated application specialists ensure your CTS™ journey is supported every step of the way, ensuring your process is scalability-ready and GMP-compliant.
