Cell and gene therapies require innovative processing technologies to meet the demands of moving from research into clinical and commercial manufacturing. Technologies must be designed to increase safety, efficiency and provide cost effective solution. The ekko™ acoustic cell processing system by MilliporeSigma provides a robust platform for cell processing that advances current methods for the concentrate-wash step and a number of other applications. This innovative technology delivers a closed and automated process, thereby increasing efficiency and reducing risk of contamination.
The concentration-wash step of cell processing can be particularly challenging, and it is critical for both research and therapeutic applications. Clogged filters, low cell recovery and/or low viability, long wash cycles requiring large buffer volumes, high levels of shear stress for cells, and sometimes open or manual operations traditionally plague this step. Due to the level of complexity, it is difficult to scale up and automate for commercial manufacturing. The ekko™ system uses acoustic wave technology to provide a gentler, efficient, closed and automated system as an alternative to current mechanical and filtration methods.
ekko™ system Technology
The ekko™ system is a novel GMP-ready technology for cell and gene therapy manufacturing, which utilizes acoustophoresis to gently manipulate cells in suspension with ultrasonic waves. This innovative technology uses ultrasonic waves to capture cells in a three-dimensional standing wave and is capable of separating them based on physical parameters like size and density. This tunable system can be used to isolate cells from culture media that is typically performed with porous filters or centrifugation, but it has none of the disadvantages since cells are not exposed to sheer forces as they are in these situations.
The ekko™ platform is designed to replace all concentration and washing unit steps during cell bioprocessing in manufacturing cell therapies workflows like CAR-T therapy. Whether you need to process an apheresis product or are harvesting from a bioreactor, the ekko™ system processes cells continuously without interruption while maintain viability owing to the low energy acoustic mechanism of the platform. Cells that have been successfully processed in the ekko™ include: T cells, mesenchymal stem cells (MSCs) and pluripotent stem cells (PSCs). Intuitive controls and a purpose-built single use cartridge make the ekko™ system a flexible and scalable fit-for-purpose cell therapy manufacturing tool for early stage research through to GMP production.
- Gentle: Manipulation of cells imparts minimal energy and stress to maintain high viability
- Scalable: Acoustic technology allows for continuous operation suitable for autologous or allogeneic therapies
- Simplified: Process small or large volumes of materials on the same platform
- Cost-effective: The modular design and single-use cartridges enables one platform to be used for many applications
- Time-savings: Multi-use platform technology simplifies cell therapy manufacturing
- GMP capable: Closed and automated design
ekko™ system Flexibility
The flexibility of the system makes it tunable for a wide range of inputs and final concentrations, yields or processing times. For example, PSCs are often cultured as aggregates. This necessity makes it difficult to perform media exchanges in a bioreactor setting, which has been a limitation to scale-up. The ekko™ system allows for efficient media exchanges with minimal loss of aggregates across multiple exchanges, while also removing unwanted single cells before returning aggregates to the bioreactor. The gentle handling of the aggregates ensured there is no impact to morphology, cell function or differentiation potential of the cells after harvest.
Based on acoustic differences, the ekko™ can be utilized to harvest T cells from a heterogeneous population, separating the TCR+ cells from TCR- cells during allogeneic CAR-T manufacturing process. This is a magnetic bead-free cell separation solution that can save time and money as well as improving cell quality.
While initially optimized to work with CAR-T processes, the ekko™ technology can be applied to many other therapies based on iPSCs, natural killer cells and more, in both autologous and allogeneic formats, and is poised to accelerate the clinical pipeline of many cell therapies.
For more information on these specific applications and more utilizing the ekko™ system, please visit https://www.fdsonics.com/index.php/supporting-material