Cynata Therapeutics (ASX:CYP) has achieved a world first breakthrough in the manufacture of stem cells and is now set to scale up manufacturing of its mesenchymal stem cells for therapeutic use.
The company’s lead Cymerus™ stem cell manufacturing process has now been successfully validated at a key U.S. biomanufacturing site.
Extensive trials at Waisman Biomanufacturing in Madison, Wisconsin have now confirmed this state-of-the-art stem cell manufacturing process is capable of producing MSCs for therapeutic application, consistently, efficiently and economically, in a Good Manufacturing Practice (GMP) production environment.
Importantly, the Cymerus™ process uses an effectively limitless starting material – a bank of induced pluripotent stem cells (iPSCs) – and a patent-protected process to derive MSCs for commercial use.
This sets it apart from existing methods of MSC production, which require a continuous supply of new tissue donations.
As a result, there will be no need to repeatedly source, screen, and test new donors and issues with donor-to-donor variability will not arise.
The company will also not have to excessively expand MSCs in culture in order to generate the vast numbers of cells required to provide commercially-viable treatments for major diseases.
This clears the path towards low cost, cutting edge cell therapy.
Cynata will now move to manufacture its GMP-grade Cymerus™ MSC product and expedite its clinical trial and collaboration programs.
A Phase I human clinical trial of the Cymerus™ stem cell technology is currently in planning stage, with discussions underway with regulatory authorities to ascertain and clarify the likely regulatory path for this cutting-edge therapeutic product.
The proposed clinical study is intended to examine the impact of these manufactured cells on patients affected by graft-versus-host disease.
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