Eurogentec Completes Manufacture of 150 g of GMP Plasmid DNA for Major Pharmaceutical Company
March 31st 2015, Seraing, Belgium – Eurogentec s.a. – Eurogentec, a custom service and contract manufacturing organization (CMO), announced today that its GMP Drug Substance manufacturing facility has completed the production of 150 grams of plasmid DNA (pDNA). The GMP plasmid was manufactured and released as a single GMP batch and is the largest batch of pDNA ever manufactured. 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.
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."
About Plasmid DNA
Plasmid DNA offers significant opportunities in the treatment of genetic, acquired or infectious diseases such as cystic fibrosis, cancer or influenza. The technology has a long history of safety and is characterized by high stability and being non-infectious. Aside from the therapeutic advantages, plasmid DNA holds a number of advantages from a manufacturing point of view. The product can be more rapidly and more cost-effectively produced compared to other biopharmaceuticals due to the platform nature of plasmid DNA manufacturing; this also makes plasmid DNA interesting for use in pandemic situations.
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. Eurogentec’s two business units fully support diagnostic and drug development projects from early R&D to commercial phases. Headquartered in Belgium and with strategically located subsidiaries worldwide, the Eurogentec Group employs a team of 325 people.
Kaneka is an innovation-oriented chemical company. Traditionally the company has been active in polymers, fermentation, biotechnology and electronics, as well as other fields. Business activities now span a broad spectrum of markets ranging from plastics, EPS resins, chemicals and foodstuffs to pharmaceuticals, medical devices, electrical and electronic materials and synthetic fibers. The life science related activities are currently one of the strategically important domains for Kaneka. The company has been a pioneer among Japanese chemical companies in establishing overseas operations, beginning in 1970 with a subsidiary in Belgium.
Kaneka Corporation is a company headquartered in Osaka-Japan, with subsidiaries in the United States, Belgium, Germany, Singapore, Malaysia, China, Australia, Vietnam, India, South Korea, Taiwan, Indonesia and Brazil. Net sales in the last financial year were 525 billion Yen. Kaneka employs more than 8,900 people worldwide.