| 书目名称 | Cell Therapy | | 副标题 | cGMP Facilities and | | 编辑 | Adrian P. Gee | | 视频video | | | 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 | | 图书封面 |  | | 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 | | 关键词 | cell processing facilities; cell product manufacturing; cell therapy standards; regulation of cell ther | | 版次 | 2 | | doi | https://doi.org/10.1007/978-3-030-75537-9 | | isbn_ebook | 978-3-030-75537-9 | | copyright | Springer Nature Switzerland AG 2022 |
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发表于 2025-3-21 16:15:55
