SERAING, België–(BUSINESS WIRE)– Kaneka Eurogentec, een door de FDA geaccrediteerde organisatie voor uitbestede ontwikkeling en productie van biomoleculen, heeft vandaag bekendgemaakt dat zijn directie heeft ingestemd met de bouw van een hypermoderne GMP-faciliteit. De nieuwe vestiging komt naast de huidige faciliteit van het bedrijf te staan en wordt uitgerust met een bioreactor van 2200 liter. De uitbreiding stelt het bedrijf in staat op grote schaal biofarmaceutische middelen te produceren, zoals recombinante eiwitten, delen van antilichamen en plasmiden.
De faciliteit heeft de capaciteit voor grootschalige productie met behulp van innovatieve Eurogentec-technologieën, zoals de verbeterde productie van complexe eiwitten door secretie uit gist en de productie van plasmiden in kiloladingen voor virale en niet-virale gen- en celtherapieën.
Kaneka Eurogentec Announces the Construction of a New Large Scale Pharmaceutical Grade Biologics Manufacturing Facility
New site expansion will allow the GMP production of kg scale plasmid DNA and recombinant protein intended for clinical phases and commercialization
SERAING, Belgium–(BUSINESS WIRE)– Kaneka Eurogentec, a custom service and FDA inspected contract development and manufacturing organization (CDMO), announced today that its board has approved the construction of a new state of-the-art GMP facility adjacent to its current facility and equipped with a 2200 L fermenter. The expansion will allow for the large scale production of biopharmaceuticals including recombinant proteins, antibody fragments and plasmid DNA.
A new facility responding to current market needs
The multi-product facility will include the capability for large scale production using innovative Eurogentec technologies such as the improved production of complex proteins by secretion from yeasts and the production of kilo-scale plasmid DNA for viral and non-viral gene and cell therapies. This expansion will be complementary to the current capabilities and together will provide small and industrial scale production. It will offer on a single site to clients on a worldwide basis biologics manufacturing intended to clinical studies and commercialization.
Lieven Janssens, Executive Vice President at Kaneka Eurogentec stated “The rapid growth in cell and gene therapy products is driving the need for large batches of plasmid DNA; our existing pharma and biotech customers have already expressed the need for kilo-scale manufacturing capabilities and we have developed equipment and methods to respond to these needs with the new facility”.
Ingrid Dheur, Vice President Biologics at Kaneka Eurogentec added “Complex protein structures such as new antibody formats are generating rapid growth in the use of Pichia pastoris for these types of biologics; the new facility will also be equipped for large scale production using such yeast expression systems”.
Construction is expected to start in autumn of 2017. The state-of-the-art facility will be equipped for the production and purification of new biomedicines using cost-effective and safe microbial strains and will include the installation of a 2200 L fermenter, harvest and purification equipment for all expression strategies. Additionally, the expansion will result in the hiring of 40 full time scientific staff trained in the production of GMP therapeutic products.
About Kaneka Eurogentec
Eurogentec was founded in 1985 as a spin-off company of the University of Liège (Belgium). Kaneka Eurogentec contributes to improving health and fighting diseases by supplying products and services to scientists involved in life science research, molecular diagnostics, and therapeutic developments. The Liège-based company is recognised as one of the major suppliers in the field of genomics and proteomics as well as a trusted Contract Development and Manufacturing Organisation (CDMO) for the bio-production of pharmaceuticals (vaccines and medicines
In 2010, Eurogentec, renamed Kaneka Eurogentec in April 2017, became part of Kaneka Corporation, a large Japanese chemical company focusing on technology and innovation.
About Kaneka Corporation
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 Eurogentec S.A.