JGC : Awarded Contract for Construction of manufacturing facility for ATMPs and mRNA Vaccine Ingredients

JGC Holdings Corporation (Representative Director, Chairman and Chief Executive Officer: Masayuki Sato) is pleased to announce that JGC Japan Corporation (Representative Director and President: Shoji Yamada) has been awarded a construction project for a new manufacturing facility by Takara Bio Inc. The facility will serve as a new CDMO¹ site for the manufacture of Advanced Therapy Medicinal Products (ATMPs), including gene therapy vectors and nucleic acid medicine.

The project calls for JGC to provide engineering, procurement, construction, and validation (EPCV) services for the Center for Gene and Cell Processing III on-site at the Takara Bio head office in the city of Kusatsu, Shiga. The lump-sum contract is for an undisclosed amount, with completion of construction scheduled for 2027.

As a dual-use facility, in the event of outbreak of an infectious disease (emergency), the Center will manufacture the ingredients for mRNA vaccine and virus vector vaccine, and the enzymes for mRNA vaccine production in accordance with Japanese government directives. In normal times, the Center will manufacture ATMPs including gene therapy vectors and nucleic acid medicine, as an integral part of Takara Bio's CDMO business.

Moreover, the Center will respond flexibly in developing manufacturing processes and manufacturing ATMPs needed in the market by applying single-use technology² with GMP-compliant³ manufacturing and quality control functions for simultaneous manufacturing of multiple products.

JGC is a leading contractor in Japan's pharmaceutical sector, having participated in the design and construction of numerous plants since the 1980s. In our view, a decisive factor in securing this contract was the ability to develop proposals drawing on our extensive expertise and track record, thereby meeting the needs of Takara Bio.

The complex molecular structure of ATMPs is difficult to manufacture and advanced engineering is required. JGC will continue to contribute to the development of this sector through optimal solutions that respond to diverse client needs in the area of new modalities such as ATMPs.

1 CDMO: Contract Development and Manufacturing Organization. This business involves contracted work from developing drug manufacturing processes to producing investigational and commercial drugs.

2 Single-use technology: A technology for manufacturing pharmaceutical products adopting equipment such as bags, filters, tubes, sensors, etc. that are used only once. In contrast with equipment and facilities that are repeatedly used, this technology not only eliminates the need for cleaning and sterilization before and after the manufacturing process, but also simplifies the configuration equipment in accordance with the manufacturing process.

3 GMP: Good Manufacturing Practice is that part of Quality Management which ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization, Clinical Trial Authorization, or product specification.

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