書目名稱 | Cell Therapy | 副標題 | cGMP Facilities and | 編輯 | Adrian P. Gee | 視頻video | http://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 |  | 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 | doi | https://doi.org/10.1007/978-3-030-75537-9 | isbn_ebook | 978-3-030-75537-9 | copyright | Springer Nature Switzerland AG 2022 |
The information of publication is updating
|
|