News

FUJIFILM Diosynth Biotechnologies Breaks Ground on Large-Scale Microbial Manufacturing Facility Expansion in Billingham, UK

BILLINGHAM, UNITED KINGDOM, September 22, 2022 – FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, announced today the start of the expansion of its large-scale microbial manufacturing facility located at the Billingham, UK campus. The company held a small internal ceremony at the site on 6 September 2022. To accommodate the increasing demand for FUJIFILM Diosynth Biotechnologies’ microbial development and manufacturing services, the expansion will include over 1858 square meter (20,000 sq. ft.) of modular clean room space, including two primary recovery and refolding suites, two purification suites and a column packing room. The new space is designed to maximize the emerging SymphonX™[1] technology for clinical and commercial manufacturing. Once the expansion is complete in late 2023/early 2024, the manufacturing capacity of the large-scale microbial production facility will increase by 70%. “Through innovation and the utilization of high-throughput technologies, we

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FUJIFILM Diosynth Biotechnologies breaks ground on a USD 1.6 billion (11 billion Danish kroner) expansion in Hillerød, Denmark

Hillerød, Denmark, September 12, 2022 – FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, held a groundbreaking ceremony today to celebrate the start of its new expansion project to transform the Denmark site into the largest end-to-end CDMO in Europe[1]. The expansion project will strengthen FUJIFILM Diosynth Biotechnologies’ cell culture manufacturing services in Denmark and create 450 new jobs. Participating in the ceremony were Jeppe Kofod, Danish Minister of Foreign Affairs, Kirsten Jensen, Mayor, Hillerød municipality, Manabu Miyagawa, Japanese Ambassador to Denmark, and Kenji Sukeno, Chairman, Representative Director and Board Chairman, FUJIFILM Holdings Corporation. This expansion is funded by a major capital investment of USD 1.6 billion (11 billion Danish kroner) by FUJIFILM Corporation. The expansion will increase the capacity of the current site by adding 8 x 20,000L bioreactors and two downstream processing streams. When the expansion is completed,

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FUJIFILM Irvine Scientific Launches Heavy Oil for Embryo Culture: Optimized Protection for the IVF Laboratory

Offering ideal handling viscosity with added confidence from rigorous testing procedures SANTA ANA, Calif., July 26, 2022– FUJIFILM Irvine Scientific, Inc., a world leader in the innovation, development, and manufacture of cell culture media and assisted reproductive technologies (ART), today announced the launch of its Heavy Oil for Embryo Culture, a sterile mineral oil with an optimal weight viscosity that provides the ideal balance between ease of use and protection. Common concerns within the IVF Laboratory for embryo development during in vitro culture include media evaporation, changes in osmolality, and pH shifts due to the small volume of media used. Heavy Oil for Embryo Culture addresses those concerns with the ideal viscosity to provide an optimal in vitro environment for embryo development. To ensure the utmost quality, each raw material lot of Heavy Oil for Embryo Culture is validated using FUJIFILM Irvine Scientific’s genetic mouse embryo assay MEGA, a bioassay

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Fujifilm to Invest USD 1.6 billion to enhance and expand its global offering of cell culture manufacturing services

TOKYO – FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) today announced the investment of USD 1.6 billion to enhance and expand the cell culture manufacturing services of FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, and world-leading contract development and manufacturing organization (CDMO). This investment will enhance FUJIFILM Diosynth Biotechnologies’ sites in Hillerød, Denmark, and Texas in the United States.  As part of this investment, FUJIFILM Diosynth Biotechnologies is further expanding its capacity to support large-scale cGMP fed batch production by adding 8 x 20,000L bioreactors and two downstream processing streams in its Hillerød, Denmark facility.  The additional production capacity will make the Hillerød facility the largest end-to-end CDMO in Europe, offering a total of 20 x 20,000L bioreactors for drug substance production complemented by comprehensive drug product and finished goods services. The investment is expected to create approximately 450 jobs. The Denmark facility will be enhanced with

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Fujifilm Celebrates Four Recent Recipients of Fujifilm Fellowship at Harvard Medical School

Annual program aims to advance translational medical science research and education CAMBRIDGE, Mass. — FUJIFILM Holdings America Corporation (Fujifilm), today announced that four doctoral students have been awarded the Fujifilm Fellowship at Harvard Medical School (HMS). Since its launch in 2019, the program has now provided 17 fellowships for PhD students who are enrolled at HMS and focused on translational medicine, the process of applying basic research in the laboratory for new therapeutic development. The mission of the program is to equip promising scientists with the specialized skills needed to translate their research findings into next-generation medical solutions for patients. Specifically, the program awards two years of research funding to students from across the nine HMS-based life sciences Ph.D. programs. HMS leadership selects all program beneficiaries. “Taking new therapies from bench to bedside requires exacting work carried out by dedicated and innovative scientific thinkers,” says Yutaka Yamaguchi, general manager, Life

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FUJIFILM Irvine Scientific Acquires Exclusive License for Artificial Intelligence for IVF

The Company looks to expand the use of AI in efforts to improve IVF success SANTA ANA, Calif., – FUJIFILM Irvine Scientific, Inc., a world leader in the innovation, development, and manufacture of cell culture media and assisted reproductive technologies (ART), today announced it has exclusively licensed the intellectual property relating to artificial intelligence (AI) for image-based evaluation of human embryos to improve in-vitro fertilization (IVF) success rates. The technology was developed and patented jointly by investigators from Brigham and Women’s Hospital and Massachusetts General Hospital with expertise in artificial intelligence, biomedical engineering and IVF. Terms of the deal were not disclosed. FUJIFILM Irvine Scientific plans to offer non-exclusive licensing of the technology to companies wishing to advance the use of AI and image-based tools in reproductive healthcare and will immediately be seeking agreements, globally. This image-based technology has the fundamentally enabling advantage of no capital investment while seamlessly merging

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Fujifilm Life Sciences Showcases its Comprehensive Solutions to Support Advanced Therapies at BIO2022

Fujifilm-sponsored educational session to spotlight microbiome therapeutics development innovation Cambridge, Mass. – Fujifilm Life Sciences, a portfolio of companies with comprehensive solutions ranging from Bio CDMO services to drug development support, and including induced pluripotent stem cells (iPSCs), cell culture media, and reagents, today announced that it will have a unified presence at BIO2022 (June 13-16) at the San Diego Convention Center in San Diego, California. Fujifilm Life Sciences will showcase each company’s individual unique solutions, explore new business partnerships, and sponsor an interactive panel educational session on microbiome therapy development. “The many and diverse offerings of Fujifilm Life Sciences support and accelerate the discovery, development, manufacturing and commercialization of new therapies,” said Yutaka Yamaguchi, general manager, Life Sciences Business Division, FUJIFILM Corporation; chairman and chief executive officer, FUJIFILM Irvine Scientific, Inc. “As one Fujifilm, BIO2022 gives prospective partners a sense of the synergies and depth of experience Fujifilm can provide

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Fujifilm Begins U.S. Clinical Phase 2a Study of FF-10832 in Combination with KEYTRUDA® (pembrolizumab, Merck & Co., Inc., Rahway, N.J., U.S.A.) for Patients with Advanced Solid Tumors

TOKYO ― FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) today announced that it has begun implementation of a phase 2a study in the U.S. to evaluate safety, tolerability, and preliminary efficacy of FF-10832, a liposomal drug candidate, in combination therapy with Merck & Co., Inc., Rahway, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for patients with advanced solid tumors. FF-10832 is a liposomal formulation which encapsulates gemcitabine*1, an approved anti-cancer agent indicated for the treatment of a variety of solid tumors. The primary focus of the trial is to establish the safety and tolerability of FF-10832 in combination with KEYTRUDA in patients with advanced solid tumors, and evaluate its preliminary efficacy in non-small cell lung cancer (NSCLC)*2 and urothelial cancer (UC)*3 patients who have progressed after standard therapy, including immune checkpoint inhibitor therapy. This trial will enroll up to 100 patients in two indications (UC and NSCLC) into one

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FUJIFILM Cellular Dynamics Launches Parkinson’s Disease iCell DopaNeurons featuring LRRK2 and GBA Mutations

Leverages iPSCs derived from participants in The Michael J. Fox Foundation for Parkinson’s Research’s landmark study, PPMI MADISON, Wis. – FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cell (iPSC) products, announced today the launch of Parkinson’s disease (PD) iCell DopaNeurons featuring LRRK2 (G2019S) and GBA (N370S) mutations, which are common PD risk-associated mutations. These PD iCell DopaNeurons were developed and manufactured by FUJIFILM Cellular Dynamics from iPSCs derived from PD participants in The Michael J. Fox Foundation for Parkinson’s Research’s (MJFF) landmark study, Parkinson’s Progression Markers Initiative (PPMI). Through PPMI, each cell line is supported by patient clinical, imaging, genomics, and biological data. PD affects nearly 1 million people in the United States and more than 6 million people worldwide.[1],[2] Studies suggest that mutations in leucine-rich repeat kinase-2 (LRRK2) and the Glucocerebrosidase gene (GBA) are associated with an increased risk for developing

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Chimeron Bio Enters Into Manufacturing Agreement With FUJIFILM Diosynth Biotechnologies to Advance its RNA Oncology Candidates

Philadelphia, PA and College Station, TX – Chimeron Bio, an RNA company developing self-amplifying RNA (saRNA) vaccines and therapeutics designed on its proprietary ChaESAR™ RNA delivery platform, today announced it has entered into a manufacturing agreement with FUJIFILM Diosynth Biotechnologies (FDB), a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies, to advance the Company’s Oncology portfolio to the clinic.  Chimeron Bio selected FUJIFILM Diosynth Biotechnologies as its partner for the transfer and scale up of their drug substance manufacturing process. Drug substance manufacturing will be carried out in FUJIFILM Diosynth Biotechnologies’ state-of-the-art cGMP manufacturing facility in College Station, Texas.  Materials from this partnership will help facilitate Chimeron’s IND-enabling work and entry into the clinic.  “We selected FUJIFILM Diosynth Biotechnologies as our manufacturing partner because of their proven track record in the advanced therapies space,” said Jolly Mazumdar,

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