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news.Stemedica Cell Technologies has signed, through its subsidiary Stemedica International, an agreement with Smith & Nephew to take over its commercial grade cell manufacturing facility in Lausanne, Switzerland.
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The facility has been approved by the Swiss Agency for Therapeutic Products ("Swissmedic"), the Swiss equivalent to the US FDA.
Stemedica has fully executed the transfer of its proprietary BioSmart Technology Platform which allows the company to produce multiple stem cell products for use in the treatment of several medical conditions currently in clinical trials in the US and internationally.
Through a prior collaboration, Stemedica had initiated a technology transfer to this facility and had completed several engineering runs. This complementary operation will serve to augment Stemedica’s San Diego-based manufacturing facility which is licensed for clinical grade stem cell production. Stemedica plans to begin staffing the Swiss facility immediately and anticipates being fully operational in 2016.
Stemedica International business manager David Cheatham said: "Recommissioning an existing, high-quality facility, is a cost-effective, time-efficient solution for Stemedica to support the ever-growing demand for the Company’s unique stem cell products.
"With plans to add Swiss, European and Asian clinical trial sites, availability of a Phase III and commercial facility to manufacture the Company’s proprietary allogeneic stem cell lines will enable these important trials to move forward quickly and efficiently."
Stemedica president and chief medical officer Nikolai Tankovich said: "The addition of the Swiss facility is a major step forward for Stemedica, establishing the Company as a Phase III and commercial manufacturer of multiple lines of stem cell products and preserved stem cell proteins. Stemedica continues to achieve significant milestones as a global leader in stem cell manufacturing."
Stemedica chief technology officer Alex Kharazi said: "The Swiss facility not only increases Stemedica’s manufacturing capacity for North America and Asia, but it will also allow for the production of European Union-compliant products. This facility enables Stemedica to provide its proprietary stem cell technology to meet the growing needs of its subsidiaries and geographic distribution partners."