Cynata claims stem cell world first
THE ROADHOUSE PHARMACY: Cynata Therapeutics (ASX: CYP) has claimed a world first breakthrough in the manufacture of stem cells and is now set to scale up manufacturing of mesenchymal stem cells (MSCs) for therapeutic use.
The company’s lead platform technology is a new stem cell manufacturing process known as Cymerus, which Cynata says has just been validated at a biomanufacturing site in the United States.
According to Cynata, trials carried out at Waisman Biomanufacturing in Madison, Wisconsin have now confirmed the company’s 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.
The important factor to come out of the trials is that the Cymerus process uses, what the company described as being 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, Cynata claims, 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.
This means there will be no need to repeatedly source, screen, and test new donors and issues with donor-to-donor variability will not arise.
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 the product.
“An equity research report compiled last year by respected biotech analyst Stuart
Roberts saliently noted that should Cynata demonstrate an ability to make cells at industrial scale under GMP then it would be in a position to be a ‘genuine Stem Cell Revolutionary’,” Cynata Therapeutics chief executive officer Dr Ross Macdonald said in the company’s announcement to the Australian Securities Exchange.
“We have just achieved this 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.”
Macdonald went on to say that one of the big issues facing regenerative medicine companies was how to produce enough stem cells consistently, reproducibly and economically for clinical and commercial benefit.
“Our international manufacturing partner has now confirmed our proprietary process can achieve this in a GMP manufacturing environment,” he continued.
“This is a key requirement for pharmaceutical companies as they move to capture the opportunities presented by stem cell medicine.
“An abundance of stem cells clears a path toward low cost, cutting edge cell therapy.”
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Website: www.cynata.com