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Cell therapy = cGMP facilities and m...

Gee, Adrian P.

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Cell therapy = cGMP facilities and manufacturing /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Cell therapy/ edited by Adrian P. Gee.
Reminder of title:	cGMP facilities and manufacturing /
other author:	Gee, Adrian P.
Published:	Cham :Springer International Publishing : : 2022.,
Description:	x, 692 p. :ill. (some col.), digital ;24 cm.
Contained By:	Springer Nature eBook
Subject:	Cellular therapy. -
Online resource:	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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245 1 0 $a Cell therapy $h [electronic resource] : $b cGMP facilities and manufacturing / $c edited by Adrian P. Gee.
250 $a Second edition.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2022.
300 $a x, 692 p. : $b ill. (some col.), digital ; $c 24 cm.
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.
650 0 $a Cellular therapy. $3 894647
650 1 4 $a Cell Biology. $3 892383
650 2 4 $a Drug Safety and Pharmacovigilance. $3 2108855
650 2 4 $a Facility Management. $3 891241
700 1 $a Gee, Adrian P. $3 3589518
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856 4 0 $u https://doi.org/10.1007/978-3-030-75537-9
950 $a Biomedical and Life Sciences (SpringerNature-11642)