Manufacturing

Five drug substances (defibrotide, heparin, urokinase, sulglycotide, and condroitins) are currently manufactured by Gentium and marketed in Italy and other countries by several different companies.

Gentium has developed efficient manufacturing methods and controls in accordance with current GMPs assuring the drug's potency, identity, strength, quality, and purity. Gentium's aim is to build quality into every process we develop and every product we make, as patients with rare diseases merit the same quality products as patients with more common diseases.

Gentium is a leader in Europe for Urokinase production. Processes have been instituted to remove adventitious agents occurring in the starting material. For urokinase, we have added a second viral clearance step that exceeds other product approaches.

Our production technology and quality control are continuously united with the latest technological standards and international quality requirements.
The Gentium manufacturing team has extensive expertise in DNA extraction from natural sources with over 40 years of experience in this field. The facility used for the production of Defibrotide is dedicated to porcine product manufacture. This manufacturing process is a unique process involving the extraction of DNA from pig intestinal mucosa. Gentium is proud to be the first company in the world to produce therapeutic oligonucleotide products derived from natural sources. The current rise in therapeutic interest of oligonucleotides has created a whole new expanded market. Gentium, with its knowledge and experience in DNA extraction technology and naturally-derived oligonucleotide manufacture, has a commitment to be at the forefront of this field.