Cynata Validates Stem Cell Manufacturing Process at Wisconsin Bioproduction Site


The company’s new stem cell manufacturing process, known as Cymerus, has been successfully validated at Waisman Biomanufacturing’s plant in Madison, Wis., After tests confirmed that the manufacturing process for stem cells are able to produce MSCs for therapeutic purposes in a consistent, efficient and economical manner in a GMP production environment. .

Cynata claims that the Cymerus process uses a effectively unlimited starting material – an Induced Pluripotent Stem Cell (iPSC) bank – and a patent-protected process to derive MSCs for commercial use, which sets the company’s process apart from all others. existing methods of MSC production, which generally require a continuous supply of new tissue donations.

One of the main benefits of this manufacturing process is that Cynata hopes to be able to produce all of its MSCs from a single iPSC bank, resulting from a single blood donation. Therefore, it will not be necessary to search, select and repeatedly test new donors and problems of variability between donors will not arise.

Cynata CEO Dr Ross Macdonald said: “A stock research report compiled last year by respected biotechnology analyst Stuart Roberts vividly pointed out that if Cynata demonstrates its ability to manufacture cells on an industrial scale under GMP, then it would be able to be a “true stem cell revolutionary”.. ‘”

Additionally, the use of essentially unlimited starting material means that it will not be necessary for Cynata to overextend cultured MSCs in order to generate the large number of cells needed to provide commercially viable treatments for the major ones. diseases.

Macdonald said that one of the biggest issues facing regenerative medicine companies is how to consistently and economically produce enough stem cells for clinical and commercial benefit.

Our international manufacturing partner has now confirmed that our proprietary process can achieve this in a GMP manufacturing environment. This is a key requirement for pharmaceutical companies as they attempt to seize the opportunities offered by stem cell medicine. Abundance of stem cells paves the way for cutting-edge, low-cost cell therapy“, he added.

Cynata will now move to manufacturing its GMP-grade Cymerus MSC product and accelerate its clinical trials and collaborative programs. A phase I human clinical trial of Cymerus’ stem cell technology is currently in planning, with discussions underway with regulatory authorities to determine and clarify the likely regulatory pathway. The proposed clinical study aims to examine the impact of these manufactured cells on patients with graft versus host disease (GvHD).

Cynata’s announcement comes as the European Commission has approved the world’s first drug derived from stem cells. Chiesi Holoclar (an ex-vivo expanded autologous human corneal epithelial cell containing stem cells) has been approved for moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns of the eye in adults .


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