Open innovation to improve commercial success for our clients
Caladrius Biosciences, a cell therapy company with a select therapeutic development pipeline focused on immune modulation, partnered with us to develop a unique platform that enables cell therapy developers to wash and concentrate cells in a closed environment through the combination of a fluidics and counterflow centrifuge system. Given our considerable experience and track record in cell therapy automation and knowledge of counterflow centrifugation technology, we developed the hardware and handled the manufacturing of this platform.
The result is a Counterflow Centrifuge Device (CFC) platform that offers flexibility and applicability in the research and development of therapies. The device can also be used in the commercial production of therapies as they achieve regulatory approvals.
“As a technology that combines multiple operations into one automated platform, the CFC provides flexible, more efficient processes to enhance the manufacture of autologous and other patient-specific products in a cost-effective manner.”
David J. Mazzo
Mazzo, President and Chief Executive Officer of Caladrius Biosciences
Delivering innovation for the cell therapy market
The CFC platform is designed to be used in multiple stages of research and production for concentration/volume reduction, cell washing, media exchange, particle depletion and short-term incubation. It consists of an instrumentation platform, a novel disposable flow path, and operating and application software for automated execution of user-selected protocols.
The CFC provides a platform for flexible small-scale process suitable for GMP manufacturing of autologous cell therapies and other patient-specific products. It also enables the refinement of manual processes in an efficient and cost-effective manner prior to transitioning to scaled volume production.
CFC platform for GMP manufacturing of patient-specific cell therapy products
Designing a unique consumable
At the core of the CFC platform is a highly innovative plastic disposable cartridge. The disposable is placed into the device and rotated in a centrifuge at speeds of over 3000 rpm, while a constant flow of cell-rich fluid is introduced. Developing a disposable plastic assembly that could withstand this g-force reliably and safely while accommodating continuous fluid flow, was one of the more significant design challenges to overcome during the development of the system.
We also designed the disposable with flexibility in mind, enabling it to be used at many stages in the manufacturing process and providing a robust and repeatable technology for multiple research and production activities. It has been developed with three chamber size options (10, 50 and 75 ml), allowing the system to be utilized for a wide range of cell contraction and processing volumes which support process development for scale-up and GMP manufacturing of cell therapies.
Complex disposable designed for ease of use
Creating a flexible, easy-to-use platform
In creating the CFC, we applied a human-centered design approach to deliver a more flexible platform for the end-user. It replaces many previously complicated and manual processing steps and remains extremely simple to use despite the complex tasks performed by the consumable. For example, the device features single-handed loading and removal through a locking mechanism.
During the development, we placed CFC devices into a laboratory for real-time assessment and trial. The system was repeatedly tested and used to determine an optimal user experience and to debug process problems. As issues were identified, we remotely connected to the devices from our development office and made updates to the software or process for the next trial.
Our user-centered design approach suits many operator capability levels
More Case Studies
Below are a selection of case studies highlighting the range of problems we’ve solved to deliver innovation and business value for our clients.