Cynata achieves major stem cell manufacturing milestone

Published: 20-Feb-2015

Australian company Cynata has achieved a breakthrough in stem cell production and is now set to scale-up manufacturing of its mesenchymal stem cells for therapeutic use


Australian stem cell and regenerative medicine company Cynata has achieved a breakthrough in stem cell production 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 US biomanufacturing site. Extensive trials at Waisman Biomanufacturing in Madison, Wisconsin, have now confirmed that this state-of the-art stem cell manufacturing process is capable of producing MSCs for therapeutic applications 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 breakthrough sets Cymerus apart from all existing methods of MSC production, which require a continuous supply of new tissue donations.

Cynata will now move to manufacture its GMP-grade Cymerus MSC product and expedite its clinical trial and collaboration programmes. A Phase I human clinical trial is currently in planning stage, with discussions under way 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 (GvHD).

Chief Executive Officer, Dr Ross Macdonald, 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 allows for virtually unlimited quantities of MSCs of consistent quality to be manufactured for therapeutic use,' he said. 'We look forward to aggressively pursuing commercial applications for this game-changing therapeutic technology.'

Cynata’s Vice President of Product Development, Dr Kilian Kelly, added: ‘The company’s ability to make stem cells under GMP at scale was paramount to its endeavour. Demonstrating that we can make cells at industrial scale under GMP positions us to be at the forefront of regenerative medicine globally.’

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