Cell Therapy - cGMP Facilities and Manufacturing (Hardcover, 2nd ed. 2022)

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.

General

Imprint:	Springer Nature Switzerland AG
Country of origin:	Switzerland
Release date:	November 2021
First published:	2022
Editors:	Adrian P. Gee
Dimensions:	235 x 155mm (L x W)
Format:	Hardcover
Pages:	692
Edition:	2nd ed. 2022
ISBN-13:	978-3-03-075535-5
Categories:	Books > Business & Economics > Business & management > Management of specific areas > Management of real estate, property & plant Books > Medicine > Other branches of medicine > Pharmacology > General Books > Science & Mathematics > Biology, life sciences > Cellular biology > General Promotions
LSN:	3-03-075535-5
Barcode:	9783030755355

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