Kaneka expands its biopharmaceutical production capacity in Europe

Kaneka Corporation (Osaka, Japan; President: Mamoru Kadokura, herein after referred to as Kaneka) has decided to drastically increase its biopharmaceutical*1 production capacity in Kaneka Eurogentec S.A. (Seraing, Liege, Belgium; President: Masanobu Sugawara), a wholly owned group company in Europe. Kaneka will build a new large-scale GMP*2 production facility including a 2,200-liter fermentor and related equipment for contract development and manufacturing activities with an investment of approximately 5 billion JPY planning to start operation in 2020. This multi-product facility will increase its production capacity by approximately four times and expand the Kaneka Eurogentec Biologics business, also as a result of enhanced sales & marketing efforts.

In view of social trends such as the growing world population and the aging society, development of innovative pharmaceuticals and therapies is globally promoted. Especially, biopharmaceuticals are attracting high attention and its market is expanding year by year.

Kaneka acquired Eurogentec S.A. in 2010 as a consolidated subsidiary and has been expanding its business of CDMO (Contract Development & Manufacturing Organization) services for biopharmaceuticals produced in microbial systems by providing solutions such as process development, GMP production, and quality control for pharmaceutical companies while obtaining great trust from customers worldwide.
The facility of Kaneka Eurogentec S.A. is inspected by the US Food and Drug Administration (FDA)*3 for manufacturing drug substances of commercial biopharmaceutical products for the US market. In addition, combination of proprietary technologies brought success in mass production of GMP plasmid DNA*4which are used for DNA-based drugs and gene therapies.

Kaneka will strive to further expand its biopharmaceutical business, which is a Kaneka’s priority area, including surrounding business through Kaneka Eurogentec as a leading player for growth.

Eurogentec S.A. became a wholly owned subsidiary of Kaneka in August 2016 and was renamed to Kaneka Eurogentec S.A. on April 1, 2017.

1. Biopharmaceutical: pharmaceutical products composed of peptides, proteins, nucleic acids, etc. and produced by biotechnology such as microbial fermentation technology, cell culture technology, genetic recombination and cell fusion.
2. GMP (Good Manufacturing Practice): manufacturing and quality control system for pharmaceuticals.
3. Food and Drug Administration (FDA): US governmental agency dealing with approval and supervision of violation of products which may be used by consumers in their daily life such as pharmaceutical products, cosmetics, medical devices, veterinary drugs and toys.
4. Plasmid DNA: generic term of circular DNA existing outside of the nucleus of micro-organism such as bacteria and yeasts. It has been used in production processes of biopharmaceuticals such as proteins, and is recently expected to be applied to treatment as genetic medicinal drug.

＜Overview of Kaneka Eurogentec S.A. ＞