Cell and gene therapy is becoming one of the fastest-growing segments in the life sciences. The manufacturing process requires a complicated multi-step operation where high volumes of cells are separated, washed, and concentrated. One challenge faced by cell and gene therapy manufacturers is moving from a manual and open system to a closed and automated one. Recently a private equity backed startup developed a novel technology for a closed and automated system that can separate solids from liquids for use in gene and cell therapies. Using gentle forces to create ultrasonic waves, cells can be manipulated in a variety of ways that cannot be accomplished with traditional manufacturing techniques. Synectic Product Development was approached to develop a piece of cell processing capital equipment that would utilize this novel technology for use in cell and gene therapy manufacturing. Additionally, a single use disposable cartridge that integrates with the capital unit needed to be developed in tandem. The biggest challenge was creating a working system that could seamlessly integrate both the capital and disposable components.
Synectic's solution
First, two teams of mechanical, electronic, and software engineers, assigned to the capital and disposable projects, collaborated to refine existing design concepts and CAD models. In an effort to reduce costs, we moved an expensive “reusable” component from the original disposable cartridge design to the new capital design. In order to address the issue of integrating the capital unit with the disposable unit, both our capital and disposable teams developed an intricate fluid path. Pinch valves were added into the design to control fluid flow and path. Additionally, our engineers incorporated weight and temperature systems for enhanced user feedback. Synectic's software engineers wrote and tested firmware code on all individual sub-assemblies. Finally, we developed and tested high level control software for optimal user experience.
The result
An electromechanical closed loop cell processing system for gene therapies.
An intuitive touch screen interface for an enhanced user experience.
A disposable component that interfaces seamlessly with the capital design.
