SERAING, Belgium--(BUSINESS WIRE)--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.
“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.”
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.
About Eurogentec
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.
About Kaneka
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.