Cynata Achieves Stem Cell Manufacturing Milestone

Cynata Therapeutics has achieved a manufacturing milestone for stem cells and is now able to scale up manufacturing of its mesenchymal stem cells (MSCs) for therapeutic use. The company’s platform technology, Cymerus, has been successfully validated at  Waisman Biomanufacturing in Madison, WI, confirming this stem cell manufacturing process is capable of producing MSCs for therapeutic application, consistently and efficiently, in a GMP production environment.
 
The Cymerus process uses an effectively limitless starting material – a bank of induced pluripotent stem cells (iPSCs) – and a process to derive MSCs for commercial use. Other methods require a continuous supply of new tissue donations. Cynata expects to be able to produce all of the MSCs it will need from a single iPSC bank, derived from a single blood donation. Also, the use of an essentially limitless starting material results in significantly reduced costs.
 
Cynata will now move to manufacture its GMP-grade Cymerus MSC product and expedite its clinical trial and collaboration programs. A Phase I trial of the Cymerus stem cell technology is currently in planning stage, and is intended to examine the impact of these manufactured cells on patients affected by graft-versus-host disease (GvHD), a condition that often follows a bone marrow transplant.  
 
Dr. Ross Macdonald, chief executive officer said, “Progressing to manufacturing scale up was a “critical milestone” for the Company. “We have just achieved an important goal. Our novel method of manufacturing stem cells – the Cymerus technology – allows for virtually unlimited quantities of MSCs of consistent quality to be manufactured for therapeutic use.  We look forward to aggressively pursuing commercial applications for this game changing therapeutic technology.”