End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging
TOKYO ― FUJIFILM Corporation (President: Kenji Sukeno) is making an investment of more than 200 Billion yen (2 Billion USD) to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business (CDMO).
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, with development and manufacturing facilities across the U.S.A., U.K., and Denmark will operate the new facility. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. The new site will be built within the vicinity of an existing Fujifilm site, and is scheduled to begin operations in the spring of 2025.
“The United States is the world’s biggest market for biopharmaceuticals. I am pleased that through this large investment in the U.S.A we are able to support the development and manufacturing of new drugs that can help fulfill unmet medical needs”, said Kenji Sukeno, president of FUJIFILM Corporation. “Fujifilm will continue to promote human health and support the progress of the healthcare industry by using our cutting-edge technology and advanced facilities to provide a stable supply of high quality biopharmaceuticals.”
Fujifilm is actively investing to enhance and grow its end to end service offerings across all of its Bio CDMO sites. Most recently (June 2020) FUJIFILM Corporation invested 100 billion yen (928 million USD) in FUJIFILM Diosynth Biotechnologies’ Hillerød, Denmark site to double its large-scale cell culture manufacturing capacity and add commercial scale drug product production capabilities.
“We are leveraging our strengths in process development and manufacturing for a wide range of biopharmaceuticals such as antibodies, recombinant proteins, gene therapies and vaccines,” said Martin Meeson, chief executive officer at FUJIFILM Diosynth Biotechnologies. “We are uniquely placed to support our customer supply chain needs providing end to end services from small to large scale bulk drug substance production, through to fill-finish and final packing.”
Fujifilm has set a target to achieve an annual revenue of 200 billion yen for its Bio CDMO business* by fiscal year ending March 2025. Beyond fiscal year ending March 2026, Fujifilm expects this latest investment to boost the annual growth rate of its Bio CDMO Business to 20%, greatly exceeding market projections. Going forward, Fujifilm will continue to contribute to the healthcare industry by providing a stable supply of high quality pharmaceuticals.
* Bio-CDMO business offers services for biopharmaceuticals and small molecule pharmaceuticals.
Overview of New Site
|United States, in the vicinity of an existing Fujifilm site.
|More than 200 billion yen (2 billion USD)
|【Drug substance production line】
・8 x 20,000L bioreactors for mammalian cells
・Fully automated fill-finish system
A device for assembling a variety of syringes and equipment for automatic packaging and labeling
FUJIFILM Corporation is an operating company of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com
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