Counterflow Centrifuge Device (CFC)

The Counterflow Centrifuge (CFC) is a unique platform that enables therapy developers to wash and concentrate cells in a closed environment. This means that multiple platforms can be used in a single room as there is no risk of cell carry-over, which limits an open development process to one therapy development per clean-room. The CFC platform offers great flexibility in that it can be used in multiple stages of both research and production for concentration/volume reduction, cell washing, media exchange, particle depletion, and short-term incubation.

Core to the advantages of the CFC platform is a highly innovative consumable. This consumable is continuously spun in a centrifuge while a constant flow of cell-rich fluid is introduced. Centrifugal force separates and washes desired cells thoroughly (in a closed manner) enabling multiple patient samples to be processed in the one room on parallel platforms. The consumable is designed with flexibility in mind, enabling it to be used at a number of stages of the manufacturing process providing a robust and repeatable technology for multiple research and production activities.Considering the complex tasks performed by the consumable, it remains extremely simple to use, featuring single handed loading and removal through a clever locking mechanism. It has been developed with 3 chamber sizes (10, 50 and 75ml) allowing the system to be utilized for a wide range of cell concentration and processing volumes to support process development for scale-up and Good Manufacturing Practice (GMP) manufacturing of cell therapies.

The CFC is designed for incorporation into Good Manufacturing Practice (GMP) equipment as a key element in commercial manufacture of cell therapies. The closed disposable used in the CFC ensures the cells are maintained in a bacteria free and minimal particulate environment. The fact that no rotating seal is used in the disposable eliminates the possibility of contamination via a seal leak into the production environment. The continuous flow and fluidized cell bed also reduces the stress placed on cells that occurs in normal centrifuges leading to increased cell viability following processing.In summary, the CFC platform allows cells to be produced automatically, consistently and repeatedly, replacing many previously complicated and manual processing steps.

A challenge with open, manual systems in developing therapies is the potential risk of cell carry-over. This is overcome by devoting a single, high-level clean room to process a single patient therapy. The CFC being a fully closed system enables users to reduce the size, cost and complexity of the manufacturing facilities. A single room can contain many CFC devices processing multiple patient therapies which is more efficient from a cost and scale perspective. Companies with CFC technology don't require vast areas of clean rooms to produce their therapies.

As mentioned, being a closed system, the CFC is significant in that it is safer for the patient, safer for the operator and safer for the facility. The system features a highly intuitive Graphical User Interface (GUI) that provides step by step guidance to operators, including loading consumable tube sets and centrifuge consumable, significantly reducing the risk of operator error at any step.

Manually produced cell therapies are very expensive to produce and the industry will founder if significant cost reductions are not found in the production process in the longer term.This platform addresses that challenge by not only offering flexibility and applicability in the research and development of therapies, but can also be used in the commercial production of therapies as they achieve regulatory approvals.

The CFC has been designed with a focus on flexibility, both for researchers and for use in commercial production. The form is appropriate to its intended environment, including the incorporation of heavy duty construction for platform stability and to safely contain the high-speed centrifuge.Significant attention has been applied to the design of the consumable and user interface, to ensure error free operation.