Manufacturing

Europe

SOTIO manufactures investigational medicinal products for active cellular immunotherapy for European patients in its own new laboratories built in Prague in 2011. SOTIO’s production facilities meet the most stringent requirements for the sterile production of the drugs used in cellular therapy and are among the most modern in Europe.

Státní ústav pro kontrolu léčiv (the State Institute for Drug Control, ‘SÚKL’) has awarded a GMP Certificate (Certificate of Good Manufacturing Practice) to SOTIO.  Observance of these guidelines includes the monitoring of the working environment, validation of instruments, adherence to exact working procedures, use of verified (certified) mediums, and the monitoring of transport conditions. SOTIO seeks cooperation with suppliers who themselves meet the requirements of this certification.

SOTIO’s team of experts, laboratory specialists, who produce investigational medicinal products in clean spaces, is mainly composed of university graduates majoring in sciences (immunology, biochemistry, biotechnology, molecular biology, microbiology, physiology) or pharmaceutical science, or experienced high-school graduates with practical experience in laboratory work. Postgraduates with long practical experience in the industry are responsible for optimising the manufacturing procedures and quality control of the final medicinal product.

China

In September 2012, SOTIO’s representatives signed in Beijing, China, a lease agreement on space in the Huilongsem International Business Incubator (Beijing) Co., Ltd. Biotechnology Park. In this five-story building, SOTIO is occupying an area of almost 4,000 square meters comprising of back offices, laboratories and manufacturing facilities. The construction of our state-of-the-arts laboratories meeting GMP standards was completed in early 2014.