Last week we reported LeukoDx had teamed up to help GE develop a system cell therapy developers can use to comply with US Food and Drug Administration (FDA) rules requiring that harvested cells are characterized throughout the manufacturing process.
The starting point for the project will be a bench top flow cytometry platform called Accellix, which itself is based on technology LeukoDx licensed from the US National Aeronautics and Space Administration (NASA) and partners Caltech and IRIS International in 2009.
Company spokesman Allon Reiter told us “LeukoDx developed the Accellix platform on the basis of a program at the NASA to develop a compact device to perform red and white blood cell counts and differential analysis during space missions.”
The Accellix platform is a cartridge-based platform for rapid diagnostic testing and real-time disease monitoring that – LeukoDx claims - represents a significant advance in the automation of flow cytometry.
The technology uses cell surface marker analysis to detect infections, which is an approach that has a number of potential applications in industrial cell characterization according to Reiter.
“The scope of the agreement [with GE] is to understand and test the requirements the cell therapy industry would have for any product in this space.
“Flow cytometry today makes up about 25%-30% of all testing done in the broad cell therapy manufacturing” he said, adding that these analyses significantly increase production costs.