Gibco CTS Rotea Counterflow Centrifugation System for Cell and Gene Therapy Manufacture

Cell and gene therapies show enormous potential, spanning a broad range of cell types and diseases with unique process requirements. Manual, open processes commonly used for R&D are not scalable, transferable, or commercially viable whilst integrated systems are expensive and inflexible, limiting the user's ability to optimize the process. User requirements are paradoxical - Biologists performing R&D need compact, flexible, low-cost systems suitable for small volume processing in laboratories whereas manufacturing requires trained production operators working in cleanrooms using qualified equipment and processes that are efficient, scalable, and reproducible, preventing changes that could compromise product and put patients at risk.

Rotea consists of a compact, automated, multipurpose instrument, sterile single-use kit, and intuitive, visual, customizable software. Together they constitute a closed system that offers exceptional cell recovery, flexible input and output volume capability, and high throughput. Rotea is ideal for multiple processes in the workflow, including cell separation, concentration, washing and buffer exchange. Highly concentrated outputs (with volumes as low as 5 mL) contain very little buffer or carryover, optimal for autologous cell therapy applications. The compact footprint, process flexibility, and continuous flow allow the system to seamlessly scale with the process, from research through commercial manufacturing.

Rotea enables development and delivery of high-quality, affordable cell and gene therapies, ultimately increasing patient access to these life-saving therapies. Rotea is an integral module within Thermo Fisher Scientific's cell and gene therapy workflow solutions including Gibco media. Rotea's small volume capability and high cell recovery and viability, optimizes the output from precious patient material. Rotea significantly reduces labor-intensive and operator dependent processes and provides a seamless transition from R&D to commercial production. The small footprint, low volume capability and sterile single use kits reduces the lifecycle environmental impact of producing cell and gene therapies compared to traditional systems.

CTS Rotea uses counterflow centrifugation to suspend cells in a fluidized bed by exerting a constant flow force against centrifugal forces. The fluid-suspended cells are gently concentrated without ever forming a pellet in the cone and washed efficiently at unmatched recovery rates. Cells of different sizes and densities can be separated by tuning centrifugal speed and flow rate to create an imbalance of forces for PBMC isolation, RBC depletion and removal of dead cells to optimize viability. CTS Rotea's proprietary Draw Extraction Technology then lets users gently and precisely recover washed and concentrated cells from the processing chamber. Gibco's cell therapy systems (CTS) products including CTS Rotea are designed to enable GMP clinical and commercial cell and gene therapy manufacturing. They are backed by testing and regulatory support to help reduce risk and enable users to confidently move from research to clinical and commercial cell therapy development. CTS Rotea includes an OPCUA interface, an industry-standard machine communication language that enables connection to a MES/LIM or 21 CFR Part 11 compliant system. CTS Rotea also incorporates multiple sensors to monitor and protect the integrity of the closed system and programmable recovery strategies should something go wrong during processing.