The joint venture, named StemedicaAnC, will manufacture enough Stemedica developed stem cells to meet five-year revenue projections. A capacity expansion to manufacture multiple stem cell products is planned to meet anticipated long-term growth in international demand.
Korea-based AnC built its manufacturing facility at an estimated cost of $120m (€85m) over a five-year period. Gaining access to this capacity gives Stemedica a platform to produce stem cell products to international safety and quality standards for use by clients around the world.
Roger Howe, Executive Chairman of Stemedica, said: “We have invested significant time and effort in our search for a best-in-class stem cell manufacturing facility to accommodate our technology. AnC provides an excellent fit for our international business development strategy.”
Stemedica cGMP produces master stem cell bank for trials
Stemedica Cell Technologies has produced a current good manufacturing practice (cGMP) master cell bank of mesenchymal bone marrow-derived stem cells for use in clinical trials.
Producing the cGMP compliant stem cell master bank gives Stemedica the capacity to treat up to 300,000 clinical trial patients. Stemedica produced the cells at its facility in San Diego, California, US which is licensed to manufacture trial materials.
Combined, the master cell bank and its parent bank contain enough stem cells to treat 300,000 clinical trial patients. Currently these studies take place outside the US, in countries where Stemedica stem cells have regulatory approval for clinical trials.
Nikolai Tankovich, president of Stemedica, said: “We have a pending investigational new drug (IND) application to conduct a clinical trial outside the US for vascular dementia, the most common form of dementia.”
Preclinical and clinical use
Stemedica will supply the stem cells to its research and clinical trial partners around the world. Researchers in the US, where Stemedica is based, will now have access to the stem cells for use preclinical studies.
Development of master and parent cell banks for additional stem cell lines, such as neural cells and retinal pigment epithelial cells produced for human use, is ongoing. Stemedica believes creation of these cell banks is vital to meeting demand for allogeneic adult stem cell products.