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Titlebook: Cell Therapy; cGMP Facilities and Adrian P. Gee Book 2022Latest edition Springer Nature Switzerland AG 2022 cell processing facilities.cel

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發(fā)表于 2025-3-21 16:15:55 | 只看該作者 |倒序?yàn)g覽 |閱讀模式
書目名稱Cell Therapy
副標(biāo)題cGMP Facilities and
編輯Adrian P. Gee
視頻videohttp://file.papertrans.cn/223/222885/222885.mp4
概述Fully updated and expanded second edition reflects all recent developments and changes in the field.Comprehensive coverage of essential information from ethical considerations and facility management
圖書封面Titlebook: Cell Therapy; cGMP Facilities and  Adrian P. Gee Book 2022Latest edition Springer Nature Switzerland AG 2022 cell processing facilities.cel
描述.This new edition presents a fully-updated and expanded look at?current Good Manufacturing Practice (cGMP) for?cell therapy products. It provides a complete discussion of?facility design and operation including details specific to?cord blood banking, cell processing, vector production and qualification of?a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The?detailed and invaluable product information covers topics like?labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like?writing and maintaining investigational new drug applications, support opportunities in North America and the?European Union, commercial cell processing and quality testing services, and financial considerations for?academic GMP facilities. A?chapter on?future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for?any cell therapy professional involved in the?development, use, or management of?this type of?facility.?.
出版日期Book 2022Latest edition
關(guān)鍵詞cell processing facilities; cell product manufacturing; cell therapy standards; regulation of cell ther
版次2
doihttps://doi.org/10.1007/978-3-030-75537-9
isbn_ebook978-3-030-75537-9
copyrightSpringer Nature Switzerland AG 2022
The information of publication is updating

書目名稱Cell Therapy影響因子(影響力)




書目名稱Cell Therapy影響因子(影響力)學(xué)科排名




書目名稱Cell Therapy網(wǎng)絡(luò)公開度




書目名稱Cell Therapy網(wǎng)絡(luò)公開度學(xué)科排名




書目名稱Cell Therapy被引頻次




書目名稱Cell Therapy被引頻次學(xué)科排名




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書目名稱Cell Therapy年度引用學(xué)科排名




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沙發(fā)
發(fā)表于 2025-3-21 21:33:36 | 只看該作者
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發(fā)表于 2025-3-22 03:17:30 | 只看該作者
https://doi.org/10.1007/BFb0012355s (cGMP) facilities and bone marrow transplant (BMT) units of two hospitals will be described and discussed. Q-Pulse software has been available for about three decades and is now owned and supported by Ideagen PLC located in the United Kingdom. It also has a head office in the United States.
地板
發(fā)表于 2025-3-22 06:04:42 | 只看該作者
Object-Based Distributed Programminge and Genetics (CBG), the Cellular Therapy Production Center, and the Chemical GMP Synthesis Facility. The ultimate aim of these facilities is to produce and test emerging therapeutic innovations in a clinical setting while ensuring patient safety. Here, we focus on the CBG due to its broad experience with different types of biologic products.
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發(fā)表于 2025-3-22 11:12:36 | 只看該作者
rmation from ethical considerations and facility management .This new edition presents a fully-updated and expanded look at?current Good Manufacturing Practice (cGMP) for?cell therapy products. It provides a complete discussion of?facility design and operation including details specific to?cord bloo
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發(fā)表于 2025-3-22 16:20:44 | 只看該作者
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發(fā)表于 2025-3-22 20:04:28 | 只看該作者
FDA Inspectionsn Cells, Tissues, and Cellular and Tissue-Based products (HCT/Ps) (2). The latter are inspected for current Good Tissue Practices (cGTPs). This chapter recommends procedures to be followed when an audit is performed by a regulatory authority.
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發(fā)表于 2025-3-22 21:24:05 | 只看該作者
Development and Maintenance of a Quality Programpurity, and potency. This chapter describes the development and maintenance of such a quality program (QP) (Food and Drug Administration. Guide to inspections of quality systems. .. Last accessed 13 July 2020, 1999).
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發(fā)表于 2025-3-23 04:10:00 | 只看該作者
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發(fā)表于 2025-3-23 07:33:28 | 只看該作者
Design and Operation of a Multiuse GMP Facility at the City of Hopee and Genetics (CBG), the Cellular Therapy Production Center, and the Chemical GMP Synthesis Facility. The ultimate aim of these facilities is to produce and test emerging therapeutic innovations in a clinical setting while ensuring patient safety. Here, we focus on the CBG due to its broad experience with different types of biologic products.
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