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Russian Ministry of Industry and Trade Issues HSCI License for Production of Pharmaceuticals

Moscow – 14 February 2014 OJSC HSCI – The Human Stem Cells Institute (“HSCI”, MOEX: ISKJ), one of Russia’s leading biotech companies, today announces that the Ministry of Industry and Trade of the Russian Federation has issued the Human Stem Cells Institute (HSCI) a license “To engage in the production of medicinal products” (No.12785-LS-P dated 31 December 2013).

On July 11, 2013, HSCI opened in Moscow its new laboratory and production complex, which was designed and built according to GMP. The complex comprises unique clean room laboratory and production space totaling 360 square meters and an advance automated cryopreservation facility for the storage of cell-based drugs and products in a cryogenic environment (-196° С).

In addition to the cell culture product laboratory, molecular genetics laboratory, cord blood stem cell bank and reproductive tissue bank, the complex also has a biopharmaceutical production facility for the development, production and quality control for cell-based drugs, including small batch contract production of cell-based drugs for R&D companies for the purpose of holding preclinical studies and clinical trials.

Alexander Prikhodko, Deputy General Director of HSCI, commented: “Having in-house pharmaceutical production capacity designed according to GMP allows our company to produce cell-based drugs according to international quality control standards. We plan to use the new complex to develop our own products and services as well as to provide Russian and international companies with contract services for the production and commercialization of innovative drugs and technologies. With the opening of our complex R&D companies now have a real opportunity to produce innovative drugs in accordance with the highest standard, which will significantly speed up the assimilation of advanced biomedical cell-based products into healthcare practice.”

Full Version of the Press Release (221 kb)

14 February 2014