Establishing a presence in Massachusetts within the academia and pharma communities to perform cutting-edge research and innovation in the field of advanced therapies.
TOKYO ― FUJIFILM Corporation (President: Kenji Sukeno) will make a major capital investment of approximately 4 billion yen ($40 million) in FUJIFILM Diosynth Biotechnologies, a world leading Contract Development and Manufacturing Organization(CDMO) for biologics, viral vaccines and viral vectors, to establish a new process development and manufacturing facility for viral vectors and advanced therapies in the greater-Boston area. This will be the third location for viral vector CDMO services provided by FUJIFILM Diosynth Biotechnologies.
The new facility is scheduled to begin process development operations in fall 2021 and will expand FUJIFILM Diosynth Biotechnologies’ manufacturing capacity to support the growing viral vector sector, which is focused on using genes to treat or prevent disease. The new facility will house experimental and analytical equipment for viral vector and advanced therapy process development, with contract manufacturing services for early phase clinical trials beginning at the site in fall 2023.
“The strength of Fujifilm’s Bio CDMO business lies in its wide-range of capabilities: process development for a variety of biopharmaceutical such as antibodies, recombinant protein, gene therapy, vaccines, oncolytic virus and more, along with flexible facilities that can adapt to small or large scale manufacturing of drug substances, formulation and packaging,” said Takatoshi Ishikawa, senior executive vice president and chief life science officer, FUJIFILM Corporation. “We will continue to leverage our expertise in Bio CDMO to further accelerate our offerings in viral vectors and advanced therapies, with the ultimate goal of fulfilling unmet medical needs.”
“We are strategically establishing this facility in the greater-Boston area where there is a high concentration of biopharmaceutical companies and academia innovating in the field of advanced therapies,” said Martin Meeson, chief executive officer, FUJIFILM Diosynth Biotechnologies.
In 2014, FUJIFILM Corporation established viral vector manufacturing offering at the FUJIFILM Diosynth Biotechnologies’ site in Texas, U.S. As the market for viral vectors has continued to expand, Fujifilm has invested a further 13 billion yen (approx. $120 million) in the Texas site to build a new process development facility and to expand existing manufacturing facilities. More recently, FUJIFILM Diosynth Biotechnologies announced an investment to provide process & analytical development and cGMP manufacturing of viral vectors in the U.K.
“Together these three sites will enable us to respond to our customers’ needs to support their viral vector manufacturing process from early clinical stage through to commercialization, to ensure these life-saving treatments are available to patients in need,” added Meeson.
Outline of process development and drug substance manufacturing facilities
|Watertown, Massachusetts, US
|Process development facility: Equipment used in analyses and experiments related to process conditions for cell cultivation.
Drug substance manufacturing facility: Cell cultivation tanks (incl. 50Lx1, 200Lx1)
|4 billion yen ($40 million)
|Process development facility: Autumn 2021
Drug substance manufacturing facility: Autumn 2023
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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