此前于2019年11月宣布,CABIM旨在幫助新療法、藥物和技術更快地到達患者,加強波士頓作為世界生命科學首都的地位。行業-學術界研究和開發聯盟的成立是由富士膠片、哈佛大學、麻省理工學院、Cytiva(前身為GE醫療生命科學的一部分)和Alexandria Real Estate Equities,Inc.各提供同等投資,為縮短實施治療的路徑,并加速這些療法的實際應用和商業化。該聯盟將與其他合作者合作,包括Beth Israel Deaconess Medical Center、波士頓兒童醫院、布萊根婦女醫院、Dana-Farber癌癥研究所、麻省總醫院和MilliporeSigma。
該生產設施計劃有8個潔凈室,其配置將在其物理空間內生產細胞和病毒載體產品。該研究中心還將提供質量控制、實驗室、辦公室和會議室空間,從而促進該地區學術界、工業界和醫院之間的合作。為擴大波士頓的專業工人基地,該中心還將專注于開發生物制藥制造領域的人才管線,為新興專業人員提供培訓和課程。
富士膠片集團高級執行副總裁和首席生命科學官Takatoshi Ishikawa說:“富士膠片很高興與領先的學術界、工業界和教學醫院合作,探索基因修飾細胞療法的應用,并為市場帶來新的治療方案。此次合作作為集團擴大醫療戰略的一部分,利用富士膠片集團產品和服務的綜合實力,為臨床醫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新制造中心的建設,將支持40名全職員工,并將維持該中心的日常運營。該中心將于2022年初開始運作。
1月4日,富士膠片集團宣布在波士頓地區建立一個新的、獨立的、最先進的4000萬美元病毒載體和先進的治療設施。此外,正如富士膠片集團之前所宣布的,將繼續投資于其CDMO業務,擴展到包括微生物培養在內的多個領域,并且最近在細胞培養方面,投資20億美元在美國建設大規模細胞培養生產設施。該新設施將由FUJIFILM Diosynth Biotechnologies(以下簡稱FDB)運營。
今后,FDB將受托開發和制造最先進的治療藥物,如CABIM正在研究和開發的基因修飾細胞治療藥物。受托制造計劃在2022年春天開始。
在CABIM當中,FDB將利用在CDMO業務中積累的技術和專門知識進行受托制造,包括為建立基因修飾細胞治療藥物的批量生產技術進行生產工藝的開發,以及制造從非臨床到早期臨床試驗的治療藥物。此外,我們還將供應集團旗下一系列包括iPS細胞、培養基、試劑等產品支持藥物發現,為最先進的治療方法的早期實用化和商業化做出貢獻。
注:
CDMO:合同開發和生產組織的縮寫,是指除商業藥品生產外,還為制藥公司提供細胞系和工藝開發、穩定性檢測、臨床試驗藥物開發和生產服務的公司。
GMP:藥品生產質量管理規范
CABIM概述
名稱 |
先進生物創新與生產中心,PBLLC |
地點 |
馬薩諸塞州,沃特敦查爾斯市,阿森納 |
投資方 |
學術界:哈佛大學、麻省理工學院 公司:富士膠片、Cytiva和Alexandria Real Estate Equities,Inc. (每個都有20%的同等投資) |
主要活動 |
該中心將推進細胞和基因治療、基因編輯、免疫療法和生物技術方面的研發。 |
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
Name |
Center for Advanced Biological Innovation and Manufacturing, PBLLC |
Location |
The Arsenal on the Charles, Watertown, Massachusetts |
Investors |
Academia:Harvard University, Massachusetts Institute of Technology Companies: Fujifilm, Cytiva and Alexandria Real Estate Equities, Inc. (each with an equal investment of 20%) |
Summary of activities |
The Center will advance research and development in cell and gene therapy, gene editing, immunotherapy, and biotechnology. |
SOURCE FUJIFILM Diosynth Biotechnologies