富士膠片將投資超過20億美元在美國建立

新的生物制藥大規(guī)模細胞培養(yǎng)生產(chǎn)基地 ▉

從藥物原液到灌封裝和包裝的端到端一站式生物藥CDMO業(yè)務(wù)解決方案

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東京，2021年1月7日——富士膠片集團（總裁：Kenji Sukeno）為加速其生物制藥合同開發(fā)和制造業(yè)務(wù)(CDMO)的增長，投資超20億美元準備在美國建立一個新的大規(guī)模細胞培養(yǎng)生產(chǎn)基地。

FUJIFILM Diosynth Biotechnologies是富士膠片集團的子公司，在美國和英國設(shè)有研發(fā)和生產(chǎn)設(shè)施，在丹麥也將運營新設(shè)施。該新設(shè)施將提供8個2萬升生物反應(yīng)器(物理體積)的大規(guī)模原液細胞培養(yǎng)生產(chǎn)，并根據(jù)市場需求進一步擴大和增加24個2萬升生物反應(yīng)器。除了生物藥原液生產(chǎn)，該工廠還將提供商業(yè)規(guī)模的自動化灌裝和組裝、包裝和貼標(biāo)簽服務(wù)。新廠址將建在富士膠片現(xiàn)有廠址附近，計劃于2025年春開始運營。

“美國是世界上最大的生物制藥市場。我很高興通過在美國的大筆投資，我們能夠持續(xù)支持新藥的開發(fā)和生產(chǎn)，幫助滿足未被滿足的醫(yī)療需求?！备皇磕z片公司總裁Kenji Sukeno說，“富士膠片將繼續(xù)利用我們的尖端技術(shù)和先進設(shè)施，為人類健康和醫(yī)療保健行業(yè)的進步提供穩(wěn)定的高品質(zhì)生物制藥供應(yīng)?！?p>

為了加強和發(fā)展生物CDMO的端到端服務(wù)，富士膠片正在積極投資。最近(2020年6月),富士膠片集團在FUJIFILM Diosynth Biotechnologies的Hiller?d丹麥工廠投資9.28億美元，將其大規(guī)模細胞培養(yǎng)生產(chǎn)能力翻倍，并增加商業(yè)規(guī)模生物藥制劑生產(chǎn)能力。

FUJIFILM Diosynth Biotechnologies的首席執(zhí)行官Martin Meeson表示:“我們正在利用我們的優(yōu)勢開發(fā)和制造各種生物制藥產(chǎn)品，如抗體、重組蛋白、基因療法和疫苗。我們在支持客戶供應(yīng)鏈需求方面處于獨特的地位，提供從小規(guī)模到大規(guī)模生物藥原液生產(chǎn)，直至灌裝和最終包裝的端到端服務(wù)?！?p>

富士膠片設(shè)定了一個目標(biāo)，到2025年3月為止，其生物CDMO業(yè)務(wù)的年收入將達到2000億日元。在截至2026年3月的財年之后，富士膠片預(yù)計，此次投資將使其生物CDMO業(yè)務(wù)的年增長率達到20%，大大超過市場預(yù)期。展望未來，富士膠片將繼續(xù)為醫(yī)療保健行業(yè)提供穩(wěn)定的高質(zhì)量藥品供應(yīng)。

*Bio-CDMO業(yè)務(wù)為生物制藥和小分子制藥提供服務(wù)。

新址概覽

1. 地點

在現(xiàn)有的富士膠片公司廠址附近

2. 總投資

超過20億美元

3. 設(shè)施

原料藥生產(chǎn)線

·用于哺乳動物細胞的8個20000L生物反應(yīng)器

罐裝系統(tǒng)

·全自動灌裝系統(tǒng)

包裝線

·一種用于裝配各種注射器和用于自動包裝和貼標(biāo)的設(shè)備的裝置

4. 開始運營

2025年春

關(guān)于富士膠片

富士膠片是富士膠片控股公司的經(jīng)營公司。日本東京富士膠片控股有限公司憑借其在不斷追求創(chuàng)新的過程中積累的豐富知識和基礎(chǔ)技術(shù)，為全球各行各業(yè)帶來尖端的解決方案。其專有的核心技術(shù)為醫(yī)療保健、圖形系統(tǒng)、高功能材料、光學(xué)設(shè)備、數(shù)字成像和文檔產(chǎn)品等多個領(lǐng)域做出了貢獻。這些產(chǎn)品和服務(wù)基于其廣泛的組合化學(xué)、機械、光學(xué)、電子和成像技術(shù)。截至2020年3月31日的財年，該公司的全球營收為210億美元，當(dāng)時日元兌美元匯率為109日元。富士膠片致力于負責(zé)任的環(huán)境管理和良好的企業(yè)公民意識。更多信息，請訪問: www.fujifilmholdings.com

FUJIFILM Diosynth Biotechnologies是一個行業(yè)領(lǐng)先的生物制劑合同開發(fā)和生產(chǎn)組織(CDMO)，位于英國Teesside、北卡羅萊納RTP、德克薩斯College Station和丹麥Hiller?d。FUJIFILM Diosynth Biotechnologies在重組蛋白、疫苗、單克隆抗體、大分子、病毒產(chǎn)品和多種微生物、哺乳動物和宿主/病毒系統(tǒng)中表達的醫(yī)療對策的開發(fā)和制造方面擁有超過30年的經(jīng)驗。該公司提供全面的服務(wù)清單，從使用其專有的pAVEway 微生物和Apollo X細胞系系統(tǒng)進行細胞系開發(fā)，到工藝開發(fā)、分析開發(fā)、臨床和FDA批準的商業(yè)化生產(chǎn)。更多信息請訪問:www.fujifilmdiosynth.com

Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

End-to-End Single-Site Solution from Drug Substances to Fill-Finish Packaging of its Bio CDMO Business

TOKYO, January 7, 2021 — 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 Hiller?d, 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

1. Location

United States, in the vicinity of an existing Fujifilm site

2. Total investment

More than 200 billion yen (2 billion USD)

3. Facilities

Drug substance production line
8 x 20,000L bioreactors for mammalian cells
Fill-finish line
Fully automated fill-finish system
Packaging line
A device for assembling a variety of syringes and equipment for automatic packaging and labeling

4. Operation start

Spring 2025

About Fujifilm

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 Hiller?d, 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