Innovation leadership in the production
of trace elements
For more than a decade, biosyn Arzneimittel GmbH has been an innovation leader in the production of sterile and high-quality trace element compounds under clean room conditions. Since 2009, the medium-sized company headquartered in Fellbach has been in a position of producing the active ingredient sodium selenite pentahydrate – the base element for all selenium products of the company – at the internationally mandated cGMP quality level in Germany.
An essential foundation of this achievement is a production process developed specifically by biosyn. Patents have been granted for this process in Europe, the United States, and Canada, as well as in other countries. It is supported by years of experience and the inventive spirit of the biosyn staff. In addition to sodium selenite pentahydrate, the company also produces sodium selenite and sodium molybdate dihydrate.
Several active ingredients certified with CEP
CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia) have been granted for three active ingredients from biosyn Arzneimittel GmbH. This certificate confirms that the active ingredient meets the quality described in the corresponding monograph of the European Pharmacopoeia. Hence, such a certificate establishes the immediate reference to the pharmacopoeia monograph. If this active ingredient is used by a drug manufacturer in the course of the approval procedure as a component of a medicinal product, then the reference to the corresponding CEP certification is sufficient for the authorities.
The issuing authority is the European Directorate for the Quality of Medicines (EDQM), with its offices being in Strasbourg.
The CEPs have been available since 2018 for anhydrous sodium selenite (R0-CEP 2017-197-Rev 01), since 2019 for sodium selenite pentahydrate (R0-CEP 2018-212-Rev 02), and since 2020 for sodium molybdate dihydrate (R0-CEP 2019-031-Rev 01). Other important trace elements for the production of injectable liquid medicinal products of cGMP quality – made in Germany – were established at biosyn.
This quality reaches far beyond the borders of the member states of the European Union. Thus, the CEPs are accepted not only by the 38 member states of the pharmacopoeia convention, but also a series of other countries. This is of special importance to biosyn Arzneimittel GmbH because the medium-sized company serves worldwide markets.
Global market leader for high-dose selenium injections
biosyn Arzneimittel GmbH is a pharmaceutical and biotech company headquartered in Fellbach. It specializes in trace elements, is a global market leader for high-dose selenium injections, and is a developer and operating company of two worldwide unique cGMP active ingredient productions. In the biotech area, it is also active with a glycoprotein, isolated from Megathura crenulata (also commonly known as the Giant Keyhole Limpet), a sea snail species found in California. 70 percent of the turnover is generated outside of Germany, spanning 27 countries around the globe.
How does biosyn obtain its base element for the selenium products?
Selenium is not easily found on earth. It is not as flashy as gold or sparkling as a diamond. And if it is to be turned into the trace element that is so important for humans, it is a long journey.
The substance generally occurs in the form of metal selenide and sulphureous ores. The latter can be found in copper, lead, zinc, gold and iron.
The base element for the production of sodium selenite pentahydrate at biosyn Arzneimittel GmbH in Fellbach is selenium dioxide, which is obtained through the processing of sulphurous rock.
Production takes only a week
In the production facilities in Fellbach, biosyn produces more than 120 kilograms of inorganic sodium selenite pentahydrate every year for its own use. In addition, medium-sized drug manufacturers and large pharmaceutical companies are supplied with the high-quality sodium selenite for research purposes and clinical applications. The dietary supplements from biosyn with selenium and the corresponding medicinal products are manufactured by partners using the high-purity active ingredient under the constant monitoring of biosyn experts. The medium-sized family business is one of the pioneers in the implementation of internationally recognized quality standards pursuant to GMP (Good Manufacturing Practice).
By the way: Selenium (Greek for moon) was discovered in 1817 by Jöns Jakob Berzelius in the lead chamber slurry of a sulphuric acid plant.