Expansion of biopharmaceutical CDMO production capacity and development sites

「In the bio CDMO business, sales increased, helped by the expanded operation of the large-scale manufacturing facilities at the North Carolina site, which opened in the previous fiscal year.」

「In fiscal 2025, the company opened a new large-scale manufacturing plant at its North Carolina, U.S. site and began operating the first-phase investment equipment, comprising eight 20,000-liter mammalian cell culture tanks.」

「In September 2025, the company opened a new large-scale manufacturing plant in North Carolina, U.S. During 2025, it will begin operating the first-phase investment equipment at the new U.S. site, comprising eight 20,000-liter mammalian cell culture tanks, and further accelerate business growth by meeting rapidly expanding demand for contract manufacturing of antibody drugs.」

「In the Bio CDMO business, the large-scale manufacturing equipment at the Danish site, which had been under construction to meet strong demand for antibody drugs, began operating in November 2024. Six new tanks were added to the existing six 20,000-liter mammalian cell culture tanks. In the second half of 2025, the company will begin operating eight large-scale manufacturing units at its North Carolina, U.S. site. At the North Carolina site, the company announced a long-term manufacturing contract with Janssen Supply Group, LLC, part of the Johnson & Johnson group, in November 2023 and entered into a 10-year manufacturing agreement worth more than US$3 billion in total with Regeneron Pharmaceuticals, Inc. in April 2025, among other developments. Contract activity is progressing steadily toward business expansion centered on the large-scale manufacturing equipment planned for the future.」

「In response to strong demand for contract manufacturing of antibody drugs, the company announced in April 2024 that it would make a large-scale investment of approximately US$1.2 billion at FUJIFILM Diosynth Biotechnologies' North American sites to install eight new 20,000-liter mammalian cell culture tanks. To meet the needs of the rapidly growing biopharmaceutical market, the company is establishing an integrated system capable of providing contract services ranging from small- to large-scale production, active pharmaceutical ingredients through drug product manufacturing and packaging, and process development, further accelerating business growth.」

「In the Bio CDMO business, to expand operations in response to strong demand for antibody drugs, the company will bring large-scale active pharmaceutical ingredient manufacturing equipment at its Danish site into operation from fiscal 2024 and begin constructing an additional large-scale active pharmaceutical ingredient manufacturing facility at its North Carolina, U.S. site, scheduled to begin operations in 2028.」

「In November 2023, the company announced that it had secured a long-term contract from Janssen Supply Group, LLC, part of the Johnson & Johnson group, to manufacture biopharmaceuticals at a large-scale facility at its North Carolina, U.S. site, which is scheduled to begin full-scale operations in 2025. In December 2023, it announced an investment to increase production capacity at its Wisconsin and California sites in the United States to meet expected long-term growth in demand for contract development and manufacturing of cell therapies.」

「In the Bio CDMO business, revenue increased due to firm contract manufacturing of antibody drugs and contributions from improved productivity at the Danish site. In June 2023, the company established FUJIFILM Diosynth Biotechnologies Japan Co., Ltd. to expand its biopharmaceutical development and contract manufacturing business in the Japanese and Asian markets. It began providing services mainly to Japanese pharmaceutical companies and is off to a steady start. Going forward, the company will further accelerate business growth by operating globally and consistently across Japan, Asia, Europe and the United States.」

「In June 2023, the company established FUJIFILM Diosynth Biotechnologies Japan Co., Ltd. to expand its biopharmaceutical development and contract manufacturing business in the Japanese and Asian markets. Going forward, the company will further accelerate business growth by operating globally and consistently across Japan, Asia, Europe and the United States.」

「In response to strong demand for contract manufacturing of antibody drugs, the company will make a second major capital investment by adding eight 20,000-liter culture tanks at its Danish site, where production equipment can be brought online in the shortest time. This investment will increase the number of tanks of this size to 20 at the Danish site and 28 worldwide by 2026.」

「In June 2022, the company announced that it would invest a total of ¥200 billion to expand equipment at its Danish site to meet strong demand for contract manufacturing of antibody drugs and install a commercial continuous manufacturing system at its Texas, U.S. site. The system will provide GMP manufacturing equipment capable of integrated active pharmaceutical ingredient production from cell culture through purification.」

「In June 2022, the company announced that it would invest a total of ¥200 billion to expand equipment at its Danish site to meet strong demand for contract manufacturing of antibody drugs and install a commercial continuous manufacturing system at its Texas, U.S. site. The system will provide GMP manufacturing equipment capable of integrated active pharmaceutical ingredient production from cell culture through purification.」

「In June 2021, to further accelerate business growth, the company decided to invest approximately ¥90 billion in total to expand active pharmaceutical ingredient manufacturing equipment for gene therapy products and vaccines at its U.S. site and for antibody drugs and gene therapy products at its U.K. site. The expanded equipment is scheduled to begin operating in the second half of 2023.」

「In the Bio CDMO business, revenue increased substantially, reflecting strong contract process development and manufacturing at the company's sites in Europe and the United States, as well as contributions from active pharmaceutical ingredient manufacturing for a COVID-19 vaccine candidate.」

「In the Bio CDMO business, revenue increased substantially, partly because active pharmaceutical ingredient manufacturing for a COVID-19 vaccine candidate at the U.S. site contributed to performance.」

「In June 2021, to further accelerate business growth, the company decided to make total capital investments of approximately ¥90 billion at its sites in Europe and the United States. It will expand manufacturing equipment and substantially increase active pharmaceutical ingredient production capacity for biopharmaceuticals, including COVID-19 vaccines and gene therapy products for advanced medical applications, for which demand is increasing. The expanded equipment is scheduled to begin operating in the second half of 2023.」

「Together with Harvard University, the Massachusetts Institute of Technology and others, the company will participate in The Massachusetts Center for Advanced Biological Innovation and Manufacturing, PBLLC, an industry-academia joint research and development consortium for advanced therapeutic fields. Going forward, it will undertake contract process development and manufacturing for advanced therapeutics, including gene-modified cell therapies, being developed by CABIM.」

「In January 2021, to further accelerate business growth, the company announced an investment of more than ¥200 billion in the United States to establish a large-scale biopharmaceutical manufacturing site. The new U.S. system will handle not only large-scale contract manufacturing of active pharmaceutical ingredients but also end-to-end services from active pharmaceutical ingredients through drug product manufacturing and packaging. The new site is scheduled to begin operations in spring 2025. In the gene therapy field, where the market is expected to expand, the company will also invest approximately ¥4 billion to establish a site in Boston, U.S., for contract process development and active pharmaceutical ingredient manufacturing for gene therapy products. Operations are scheduled to begin in phases from autumn 2021.」

「At the same site, the company decided to manufacture, from April 2021, the active pharmaceutical ingredient required for commercial production of an antibody drug for COVID-19 developed by Eli Lilly and Company. It will contribute to making the company's COVID-19 antibody drug available in low- and middle-income countries. At its U.K. site, the company will undertake the manufacture of the active pharmaceutical ingredient for a COVID-19 vaccine candidate procured by the U.K. government from Novavax and plans to begin production in early 2021. The site will also receive capital investment to establish new facilities dedicated to process development and active pharmaceutical ingredient manufacturing for gene therapies. The facilities are scheduled to begin operations in phases, with contract process development services starting in spring 2021 and contract active pharmaceutical ingredient manufacturing starting in autumn of that year.」

「In June 2020, the company announced plans to invest approximately ¥100 billion to substantially expand manufacturing equipment at its Danish site in order to further increase biopharmaceutical production capacity. The equipment will begin operating in phases from 2022 through 2023, doubling the Danish site's production capacity for biopharmaceutical active pharmaceutical ingredients and establishing a system capable of providing end-to-end contract manufacturing at the site, from active pharmaceutical ingredients through drug product manufacturing and packaging.」

「In November 2019, the company announced a total investment of approximately ¥13 billion in development and manufacturing facilities for gene therapies, one of the business's priority areas. The process development building is scheduled to open in autumn 2021, and the expanded manufacturing equipment is scheduled to begin operating from spring 2021. Going forward, the company will use its strength in providing integrated contract services from production process development through manufacturing to further expand its business in the gene therapy field, an area of advanced medicine.」

「Through this acquisition, the company acquired large-scale production equipment, including six 15,000-liter mammalian cell culture tanks. In addition to significantly increasing production capacity, it established a system capable of quickly responding to a broad range of contract manufacturing needs, from small to large volumes.」

「In June 2019, the company announced that it had developed the industry's first high-performance, high-efficiency continuous manufacturing system covering the entire process from cell culture to purification and would begin contract process development services in autumn of that year.」

「On 1 August 2019, the company acquired all equity interests in Biogen (Denmark) Manufacturing ApS, the manufacturing subsidiary of major U.S. biopharmaceutical company Biogen Inc. The acquisition cost was approximately US$890 million.」

「In the contract process development and manufacturing business for biopharmaceuticals, which is expected to achieve strong market growth, the company announced the acquisition of Biogen (Denmark) Manufacturing ApS in March 2019. It will also make total capital investments of approximately ¥10 billion over two years from January 2019 at the U.S. site of FUJIFILM Diosynth Biotechnologies U.S.A., Inc. By further expanding production capacity through capital investment and technological development, the company will accelerate business growth by strengthening profitability through economies of scale.」

「The company will continue to expand production capacity, including by deciding to make total capital investments of approximately ¥10 billion over two years from January 2019, and will seek to expand the business through the development of highly efficient, high-productivity technologies.」

「In the Bio CDMO business, contract manufacturing using mammalian cell culture and microbial culture performed strongly, resulting in a substantial increase in revenue. The Texas, U.S. production building that began operations last fiscal year and the expanded equipment at the U.K. production process development site also contributed to higher revenue from contract manufacturing and development. The company will continue to expand production capacity and grow its contract process development and manufacturing business for biopharmaceuticals through the development of highly efficient, high-productivity technologies.」

「To respond quickly to customers' requests for increased production and further expected growth in demand, the company brought a newly constructed production building at its Texas, U.S. site into operation in January 2018.」

「In the Bio CDMO business, contract process development and manufacturing for pharmaceuticals remained firm. To respond quickly to customers' requests for increased production and further expected growth in demand, in November 2017 the company decided, ahead of its original schedule, to expand biopharmaceutical production capacity at its U.S. site and make additional capital investments in its production process development site in the United Kingdom.」

「In the Bio CDMO business, contract process development and manufacturing for pharmaceuticals remained firm. To respond quickly to customers' requests for increased production and further expected growth in demand, the company is expanding biopharmaceutical production capacity at its U.S. site and enlarging its production process development site in the United Kingdom. Alongside expanding production capacity, the company will further expand its contract process development and manufacturing business for biopharmaceuticals through the development of highly efficient, high-productivity technologies.」

「FUJIFILM Diosynth Biotechnologies Texas, LLC completed a production building that it had been constructing at a cost of approximately ¥10 billion, with a subsidy from the U.S. government, to increase production capacity. Going forward, the company plans to invest approximately ¥3 billion to install the equipment required for biopharmaceutical production and bring the facility into operation in early 2018. In the United Kingdom, it will expand the biopharmaceutical production process development site at FUJIFILM Diosynth Biotechnologies UK Limited at a cost of approximately ¥1 billion.」