For anyone interested in a well-balanced selenium status – be it to improve a nutritional deficiency or treat sepsis on an intensive care unit – selenase has become a household name in Germany and worldwide. It all started in 2009 when the pioneering researchers and developers at biosyn sought a way to apply their purification and crystallization technologies to aseptically produce the naturally occurring trace element selenium based on pharmacopeial principles and GMP standards.
A special crystallization process was their secret to success. They started with selenium dioxide (SeO2), purified it from contaminants and applied multiple stages of synthetization. The patented process they created enables sodium selenite pentahydrate to be produced as an active pharmaceutical ingredient (API) under aseptic and cleanroom conditions. Now, after an investment of € 1.5 million, the medium-sized biotech company located in Fellbach, Germany is not only poised to meet its own requirements for this trace element essential to human nutrition and health. With an annual output exceeding 200 kg, biosyn also supplies global industry’s demand for anhydrous sodium selenite and sodium selenite pentahydrate in oral and parenteral formulations. The quality-assured high degree of purity complies with the requirements of Current Good Manufacturing Practice (cGMP) regulations continually updated by the FDA.
To find out more about how cGMP and the principle of quality are practiced at the German pharmaceutical manufacturer biosyn, download their new folder: