GE calls on diagnostics systems firm LeukoDx for cell characterization tech
Related tags: Therpay, LeukoDx, FDA, Cell, GE Healthcare, Pharmaceutical, Biopharmaceutical, Manufacturing
LeukoDx will develop a cell characterization system for GE Healthcare in a deal designed to bolster the latter’s cell therapy manufacturing technology offering.
The agreement – financial terms of which were not made public – will see LeukoDx develop a technology that is capable of characterizing cells used in cell therapies more rapidly than current methods.
The Jerusalem, Israel-based technology firm will use science that underpins its Accellix technology, which is cartridge-based diagnostics platform that uses flow cytometry to rapidly analyse biological samples.
Characterization is vital to cell therapy production.
The US Food and Drug Administration (FDA) requires the identity of cells intended for therapeutic use to be confirmed using a wide range of tests, including the analysis of genotypic and phenotypic markers.
The agency also insists cells are analysed throughout the manufacturing process to make sure they have not been affected by the varying conditions under which they are grown, stored and packaged.
The analysis needed to make such determinations takes take, which has a knock on impact on production timelines.
A GE spokeswoman told us "the gold standard of cell characterization is flow cytometry which is time consuming and requires a large batch of cells that is discarded after characterization. With cell therapy workflows, we’re working with fewer numbers of valuable cells, along with time constraints on production processes.
She added that, in collaboration with LeukoDx, "we’re exploring whether there could be a method of characterization that would use smaller numbers of cells and gather the right data in less time, which would simplify and expedite cell therapy workflows from early stage research through scaled out production."
The first phase of the project will be research. The spokeswoman told us that: "This agreement between LeukoDx and GE Healthcare is to explore market requirements for cell characterization and cell therapy applications. We must first understand what customers want the product to be, before discussing commercialization of any resulting technology."