The means of producing MCAs from pluripotent precursors, and the defining pattern of MCA cell surface markers, are the subjects of US patent 7,615,374, and a number of other patent applications in process around the world, licensed to Cynata. The original, published method for producing MSCs through MCA intermediates utilised cell feeder layers derived from mice, which is not recommended for manufacturing a product for use in humans. However, a refined version of the process, which does not involve the use of feeder layers, was subsequently developed. These refinements are also the subject of patents licensed to Cynata, and form the basis for Cynata’s current feeder-free method of production, which is appropriate for the manufacture of products for human use.
The iPSCs used in Cynata’s Cymerus™ manufacturing process were derived from a fully consented donor, in compliance with the FDA’s GMP requirements, and manufactured by Cellular Dynamics International (CDI; Nasdaq: ICEL), using a non-integrating episomal reprogramming method. This method of iPSC production is also covered by a series of patents and patent applications in process, which have been licensed to Cynata.