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Cell therapy = cGMP facilities and m...

Gee, Adrian P.

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Cell therapy = cGMP facilities and manufacturing /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Cell therapy/ edited by Adrian P. Gee.
其他題名:	cGMP facilities and manufacturing /
其他作者:	Gee, Adrian P.
出版者:	Cham :Springer International Publishing : : 2022.,
面頁冊數:	x, 692 p. :ill. (some col.), digital ;24 cm.
Contained By:	Springer Nature eBook
標題:	Cellular therapy. -
電子資源:	https://doi.org/10.1007/978-3-030-75537-9
ISBN:	9783030755379

Cell therapy = cGMP facilities and manufacturing /
Cell therapy (Gee)

Cell therapycGMP facilities and manufacturing /[electronic resource] :edited by Adrian P. Gee. - Second edition. - Cham :Springer International Publishing :2022. - x, 692 p. :ill. (some col.), digital ;24 cm.

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.

ISBN: 9783030755379

Standard No.: 10.1007/978-3-030-75537-9doiSubjects--Topical Terms:

894647
Cellular therapy.

LC Class. No.: RM301.37 / .C45 2022

Dewey Class. No.: 615.89

Cell therapy = cGMP facilities and manufacturing /
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520 $a 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.
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