biosyn presents its active pharmaceutical ingredients (APIs) according to GMP standard

Fellbach/Paris – biosyn Arzneimittel GmbH, globally leading in the manufacturing and marketing of selenium-based drugs, presents its active pharmaceutical ingredients (APIs) for the first time at the Convention on Pharmaceutical Ingredients (CPhI) in Paris from 5th to 7th October 2010. Located in Fellbach (Germany), the company supplies inorganic metallic salts in pharmaceutical quality, which even meet the high quality requirements set for the production of parenterals.

The purification and crystallization technologies, developed by biosyn, enable the aseptic production of high quality inorganic metallic salts under clean room conditions, said CEO Ortwin Kottwitz at the CPhI. Patents have been applied worldwide to protect this innovative process.

The competent authority of Germany granted its GMP (Good Manufacturing Practice) certification for the new production plant in Fellbach at the end of 2009. With this production plant, biosyn is now able to provide trace element compounds for pharmaceutical companies in the required quality.

biosyn manufactures sodium selenite anhydrous and sodium selenite pentahydrate for oral and parenteral preparations, which are also used for the company’s own pharmaceutical products. The development of further trace element compounds is in progress.

At CPhI, biosyn presents itself not only as an API manufacturer but also as a partner for research and development in the field of inorganic metallic salts. Kottwitz emphasizes that biosyn provides on customer demand tailor-made development and production of trace element compounds, e.g. copper, manganese, molybdenum or chromium. In addition to GMP-compliant production, the company’s services include the preparation of the regulatory documents Active Substance Master Files (ASMF) or Drug Master Files (DMF), respectively.

biosyn Arzneimittel GmbH has more than 25 years of experience in the production of biotechnological active pharmaceutical ingredients. biosyn supplies international vaccine producers with VACMUNE® liquid, a protein derived from keyhole limpet hemocyanin (KLH), collected from a marine mollusk and used as a carrier molecule for therapeutic vaccines.

Founded in 1984, the company now has approx. 80 employees in Germany and in its subsidiaries in Austria and the USA.

 
biosyn was founded in 1984 and is one of the first European biotechnology companies. The company has approx. 80 employees in Germany and in its subsidiaries in Austria and the USA. The product range includes about 30 medicinal products from biotechnologically produced drugs and chemotherapeutics to complementary medicine, food supplements. biosyn focuses on oncology and intensive care and the patient as a whole. As a research-oriented pharmaceutical company, biosyn invests up to 25 percent of sales in R&D. The aim is to research, develop and distribute high effective and low side effect new drugs on the basis of molecular biological knowledge.