Cynata Achieves Major Stem Cell Manufacturing Milestone

20-Feb-2015 - Australia

Cynata Therapeutics 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 (MSCs) for therapeutic use. The Company’s lead platform technology – a novel stem cell manufacturing process known as Cymerus™ – 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 is a world-first breakthrough that sets Cymerus™ apart from all existing methods of MSC production, which require a continuous supply of new tissue donations.

Cynata expects to be able to produce all of the MSCs it will ever need from a single iPSC bank, derived from a single blood donation. Consequently, there will be no need to repeatedly source, screen, and test new donors and issues with donor-to-donor variability will not arise. Further, the use of an essentially limitless starting material means that it will not be necessary for Cynata to excessively expand MSCs in culture in order to generate the vast numbers of cells required to provide commercially-viable treatments for major diseases. All of these advantages will result in significantly reduced costs.

Cynata will now move to manufacture its GMP-grade Cymerus™ MSC product and expedite its clinical trial and collaboration programs.

https://www.bionity.com/en/news/151755/cynata-achieves-major-stem-cell-manufacturing-milestone.html