此前于2019年11月宣布，CABIM旨在幫助新療法、藥物和技術(shù)更快地到達(dá)患者，加強(qiáng)波士頓作為世界生命科學(xué)首都的地位。行業(yè)-學(xué)術(shù)界研究和開發(fā)聯(lián)盟的成立是由富士膠片、哈佛大學(xué)、麻省理工學(xué)院、Cytiva（前身為GE醫(yī)療生命科學(xué)的一部分）和Alexandria Real Estate Equities,Inc.各提供同等投資，為縮短實(shí)施治療的路徑，并加速這些療法的實(shí)際應(yīng)用和商業(yè)化。該聯(lián)盟將與其他合作者合作，包括Beth Israel Deaconess Medical Center、波士頓兒童醫(yī)院、布萊根婦女醫(yī)院、Dana-Farber癌癥研究所、麻省總醫(yī)院和MilliporeSigma。

該生產(chǎn)設(shè)施計(jì)劃有8個潔凈室，其配置將在其物理空間內(nèi)生產(chǎn)細(xì)胞和病毒載體產(chǎn)品。該研究中心還將提供質(zhì)量控制、實(shí)驗(yàn)室、辦公室和會議室空間，從而促進(jìn)該地區(qū)學(xué)術(shù)界、工業(yè)界和醫(yī)院之間的合作。為擴(kuò)大波士頓的專業(yè)工人基地，該中心還將專注于開發(fā)生物制藥制造領(lǐng)域的人才管線，為新興專業(yè)人員提供培訓(xùn)和課程。

富士膠片集團(tuán)高級執(zhí)行副總裁和首席生命科學(xué)官Takatoshi Ishikawa說：“富士膠片很高興與領(lǐng)先的學(xué)術(shù)界、工業(yè)界和教學(xué)醫(yī)院合作，探索基因修飾細(xì)胞療法的應(yīng)用，并為市場帶來新的治療方案。此次合作作為集團(tuán)擴(kuò)大醫(yī)療戰(zhàn)略的一部分，利用富士膠片集團(tuán)產(chǎn)品和服務(wù)的綜合實(shí)力，為臨床醫(yī)生及其患者提供個性化的改變生活的治療方案。”

首輪的7600萬美元融資將有助于創(chuàng)新制造中心的建設(shè)，將支持40名全職員工，并將維持該中心的日常運(yùn)營。該中心將于2022年初開始運(yùn)作。

1月4日，富士膠片集團(tuán)宣布在波士頓地區(qū)建立一個新的、獨(dú)立的、最先進(jìn)的4000萬美元病毒載體和先進(jìn)的治療設(shè)施。此外，正如富士膠片集團(tuán)之前所宣布的，將繼續(xù)投資于其CDMO業(yè)務(wù)，擴(kuò)展到包括微生物培養(yǎng)在內(nèi)的多個領(lǐng)域，并且最近在細(xì)胞培養(yǎng)方面，投資20億美元在美國建設(shè)大規(guī)模細(xì)胞培養(yǎng)生產(chǎn)設(shè)施。該新設(shè)施將由FUJIFILM Diosynth Biotechnologies（以下簡稱FDB）運(yùn)營。

今后，F(xiàn)DB將受托開發(fā)和制造最先進(jìn)的治療藥物，如CABIM正在研究和開發(fā)的基因修飾細(xì)胞治療藥物。受托制造計(jì)劃在2022年春天開始。

在CABIM當(dāng)中，F(xiàn)DB將利用在CDMO業(yè)務(wù)中積累的技術(shù)和專門知識進(jìn)行受托制造，包括為建立基因修飾細(xì)胞治療藥物的批量生產(chǎn)技術(shù)進(jìn)行生產(chǎn)工藝的開發(fā)，以及制造從非臨床到早期臨床試驗(yàn)的治療藥物。此外，我們還將供應(yīng)集團(tuán)旗下一系列包括iPS細(xì)胞、培養(yǎng)基、試劑等產(chǎn)品支持藥物發(fā)現(xiàn)，為最先進(jìn)的治療方法的早期實(shí)用化和商業(yè)化做出貢獻(xiàn)。

注：

CDMO：合同開發(fā)和生產(chǎn)組織的縮寫，是指除商業(yè)藥品生產(chǎn)外，還為制藥公司提供細(xì)胞系和工藝開發(fā)、穩(wěn)定性檢測、臨床試驗(yàn)藥物開發(fā)和生產(chǎn)服務(wù)的公司。

GMP：藥品生產(chǎn)質(zhì)量管理規(guī)范

CABIM概述

Fujifilm and the Center for Advanced Biological Innovation and Manufacturing Announce $76M in Funding for Manufacturing and Innovation Center

TOKYO, Jan. 14, 2021 /PRNewswire/ -- FUJIFILM Corporation (COO: Kenji Sukeno) and the Center for Advanced Biological Innovation and Manufacturing (CABIM), today announced that it has secured $76 million in financing and signed a lease for a 40,000 square-foot site in Watertown, Massachusetts at The Arsenal on the Charles, owned and operated by Alexandria Real Estate Equities, Inc. The Center will advance research and development in cell and gene therapy, gene editing, immunotherapy, and biotechnology. FUJIFILM Diosynth Biotechnologies, the Bio CDMO1 subsidiary of FUJIFILM Corporation, will provide GMP2 contract process development and manufacturing services as part of its role in the new manufacturing and innovation center.

Previously announced in November 2019, CABIM aims to help new therapeutics, medicines, and technologies reach patients faster and strengthen Greater Boston's position as the world's life science capital. The industry-academia research and development consortium was established with an equal investment each from Fujifilm, Harvard University, Massachusetts Institute of Technology, Cytiva (formerly part of GE Healthcare Life Sciences), and Alexandria Real Estate Equities, Inc. to shorten the path to implementation of therapies, and to accelerate the practical application and commercialization of these therapies. The consortium will work with other collaborators including Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, and MilliporeSigma.

The manufacturing facility is planning for eight cleanrooms, with a configuration that will produce both cell and viral vector products within its physical space. The site will also offer quality control, lab, office, and convening space to facilitate collaboration between the region's academia, industries and hospitals. The Center will also focus on developing a pipeline of talent in the field of biopharmaceutical manufacturing to expand Greater Boston's base of specialized workers, offering training and curricula to emerging professionals.

"Fujifilm is pleased to partner with leading academia, industry, and teaching hospitals, to explore the application of genetically modified cell therapies, and bring new treatment options to the market," said Takatoshi Ishikawa, senior executive vice president and chief life science officer, FUJIFILM Corporation. "This collaboration supports our larger healthcare strategy to utilize the combined strength of the Fujifilm Group's products and services to offer personalized life-altering treatment options to clinicians and their patients."

The initial $76 million fundraising round will contribute to the build of the space, support 40 full-time employees, and will maintain the Center's daily operations. The Center will commence operations in early 2022.

On January 4, FUJIFILM Corporation announced a new, separate state-of-the-art $40 Million viral vector and advanced therapy facility in the greater-Boston area. Additionally, as FUJIFILM Corporation has announced previously, the company continues to invest in growing its CDMO business across several modalities including microbial and most recently, in cell culture, with a capital investment of $2 Billion to build a large-scale cell culture manufacturing facility in the U.S. The new facilities will be operated by FUJIFILM Diosynth Biotechnologies.

1 Abbreviation for Contract Development & Manufacturing Organization which refers to companies offering services to pharmaceutical companies ranging from cell line and process development, stability testing, development and manufacturing of clinical trial drugs in addition to commercial drug manufacturing.

2 Good Manufacturing Practices

Overview of CABIM

SOURCE FUJIFILM Diosynth Biotechnologies