Kaneka expands GMP manufacturing capacity for mRNA in Kaneka Eurogentec S.A.

TOKYO -- Businesswire -- Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka)(TOKYO:4118) has decided to increase its GMP*1 manufacturing capacity for mRNA*2 in Kaneka Eurogentec S.A. (Headquarters: Liège, Belgium; President: Lieven Janssens), a wholly owned group company in Europe. We plan to start operation sequentially from the end of 2023 with a capital investment of 2 billion JPY and a production capacity that is around 5 times higher than the current capacity. Kaneka Eurogentec S.A. will grow as a leading company of biopharmaceutical CDMO*3, responding to the vigorous global demand for mRNA.

mRNA, which has been rapidly implemented in vaccines against COVID-19, is expected to be applied not only to vaccines for other infectious diseases but also to therapeutics for genetic diseases, cancer and so on. The demand for GMP manufacturing of mRNA will increase drastically with the active development of biopharmaceutical pipelines by pharmaceutical companies worldwide.

Kaneka Eurogentec S.A. is a CDMO for biopharmaceuticals inspected by the US FDA*4 and has world-class technology for producing plasmid DNA*5 and GMP manufacturing track records of over 25 years. They provide plasmid DNA, recombinant proteins, oligonucleotide*6 and so on as drug substances for pharmaceutical companies worldwide. In addition, Kaneka Eurogentec S.A. has started GMP manufacturing services for mRNA since 2020, and this capacity expansion will be utilized to expand the CDMO business.

Regarding the priority area of Health Care, Kaneka will continue to provide solutions globally for health issues through the growth of its biopharmaceutical business.

*1. GMP (Good Manufacturing Practice): A system for ensuring that products are consistently produced and controlled according to quality standards.

*2. mRNA: An RNA molecule that is transcribed genetic information of protein synthesis from DNA. It is expected to be used as vaccines and therapeutics.

*3. CDMO: Contract Development and Manufacturing Organization.

*4. 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.

*5. plasmid DNA: A general term for circular DNA molecules that exist outside the nucleus of bacteria such as E. coli and yeast, and that are passed down to daughter cells through cell division.

It is conventionally used in processes for producing biopharmaceuticals such as therapeutic proteins and has been applied to genetic medicines and vaccines in recent years.

*6. Oligonucleotide: Short polymeric sequences of nucleotides (RNA or DNA). It is used as drug substance of nucleic acid therapeutics.

[General description of Kaneka Eurogentec S.A.] Headquarters: Liège, Belgium President: Lieven Janssens Description of business: Manufacturing and sales of proteins, nucleic acids and peptides for medicinal, diagnostic and basic research uses Established: 1985 Capital: 31 million euros URL: http://www.eurogentec.com/

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