Eurogetac has successfully manufactured 150 grams of GMP grade plasmid DNA
Eurogentec SA, a contract manufacturing organization has successfully manufactured 150 grams of GMP grade plasmid DNA. The plasmid DNA was manufactured in a facility that has been inspected by the US FDA and the material is intended for use in human clinical trials to take place in the USA and Europe. A plasmid is a small DNA molecule within a cell that is physically separated from a chromosomal DNA and can replicate independently. Plasmid DNA offers significant opportunities in the treatment of genetic, acquired or infectious diseases such as cystic fibrosis, cancer or influenza.
On this achievement Ingrid Dheur, Business Unit Director at Eurogentec, stated "This successful production confirms that Eurogentec’s platform GMP plasmid production process is scalable to at least 150 g per batch; we are now evaluating steps required to reach the kilogram scale to prepare for our current clients projected needs."
Eurogentec SA, part of the Kaneka group, is a contract manufacturing organization providing custom products and services to researchers in the biological sciences, diagnostic and biopharmaceutical industries. The company operates under ISO 9001, ISO 13485 and cGMP quality systems.