دورية أكاديمية
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A novel, flexible and automated manufacturing facility for cell-based health care products: Tissue Factory.

التفاصيل البيبلوغرافية
العنوان: A novel, flexible and automated manufacturing facility for cell-based health care products: Tissue Factory.
المؤلفون: Kikuchi T; Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University (TWIns), 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan.; CellSeed Incorporated, 15F (East Wing) Telecom Center Building, 2-5-10 Aomi, Koto-ku, Tokyo 135-0064, Japan., Kino-Oka M; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan., Wada M; ABLE Corporation, 7-9, Nishigoken-cho, Shinjuku-ku, Tokyo 162-0812, Japan., Kobayashi T; Hitachi Ltd., Hatoyama, Saitama 350-0395, Japan., Kato M; Hitachi Ltd., Hatoyama, Saitama 350-0395, Japan., Takeda S; Hitachi Ltd., Hatoyama, Saitama 350-0395, Japan., Kubo H; Nihon Kohden Corporation, 1-31-4 Nishi-Ochiai, Shinjuku-ku, Tokyo, Japan., Ogawa T; Nihon Kohden Corporation, 1-31-4 Nishi-Ochiai, Shinjuku-ku, Tokyo, Japan., Sunayama H; Shibuya Kogyo Co., Ltd., 2-1, Hokuyodai, Kanazawa-Shi, Ishikawa-Ken 920-0177, Japan., Tanimoto K; Shibuya Kogyo Co., Ltd., 2-1, Hokuyodai, Kanazawa-Shi, Ishikawa-Ken 920-0177, Japan., Mizutani M; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan., Shimizu T; Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University (TWIns), 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan., Okano T; Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University (TWIns), 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan.
المصدر: Regenerative therapy [Regen Ther] 2018 Sep 19; Vol. 9, pp. 89-99. Date of Electronic Publication: 2018 Sep 19 (Print Publication: 2018).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: The Japanese Society for Regenerative Medicine. Production and Hosting by Elsevier B.V Country of Publication: Netherlands NLM ID: 101709085 Publication Model: eCollection Cited Medium: Internet ISSN: 2352-3204 (Electronic) Linking ISSN: 23523204 NLM ISO Abbreviation: Regen Ther Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: [Amsterdam] : The Japanese Society for Regenerative Medicine. Production and Hosting by Elsevier B.V., [2015]-
مستخلص: Introduction: Current production facilities for Cell-Based Health care Products (CBHPs), also referred as Advanced-Therapy Medicinal Products or Regenerative Medicine Products, are still dependent on manual work performed by skilled workers. A more robust, safer and efficient manufacturing system will be necessary to meet the expected expansion of this industrial field in the future. Thus, the 'flexible Modular Platform (fMP)' was newly designed to be a true "factory" utilizing the state-of-the-art technology to replace conventional "laboratory-like" manufacturing methods. Then, we built the Tissue Factory as the first actual entity of the fMP.
Methods: The Tissue Factory was designed based on the fMP in which several automated modules are combined to perform various culture processes. Each module has a biologically sealed chamber that can be decontaminated by hydrogen peroxide. The asepticity of the processing environment was tested according to a pharmaceutical sterility method. Then, three procedures, production of multi-layered skeletal myoblast sheets, expansion of human articular chondrocytes and passage culture of human induced pluripotent stem cells, were conducted by the system to confirm its ability to manufacture CHBPs.
Results: Falling or adhered microorganisms were not detected either just after decontamination or during the cell culture processes. In cell culture tests, multi-layered skeletal myoblast sheets were successfully manufactured using the method optimized for automatic processing. In addition, human articular chondrocytes and human induced-pluripotent stem cells could be propagated through three passages by the system at a yield comparable to manual operations.
Conclusions: The Tissue Factory, based on the fMP, successfully reproduced three tentative manufacturing processes of CBHPs without any microbial contamination. The platform will improve the manufacturability in terms of lower production cost, improved quality variance and reduced contamination risks. Moreover, its flexibility has the potential to adapt to the modern challenges in the business environment including employment issues, low operational rates, and relocation of facilities. The fMP is expected to become the standard design basis of future manufacturing facilities for CBHPs.
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فهرسة مساهمة: Keywords: Automation; CBHP, cell-based health care product; Cell processing facility; Decontamination; Manufacturing; Regenerative medicine; fMP, flexible Modular Platform
تواريخ الأحداث: Date Created: 20181208 Latest Revision: 20220330
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC6223031
DOI: 10.1016/j.reth.2018.08.004
PMID: 30525079
قاعدة البيانات: MEDLINE
الوصف
تدمد:2352-3204
DOI:10.1016/j.reth.2018.08.004