Description: 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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End Time: 2025-02-12T04:40:34.000Z
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EAN: 9783030755355
UPC: 9783030755355
ISBN: 9783030755355
MPN: N/A
Book Title: Cell Therapy: Cgmp Facilities and Manufacturing by
Item Length: 23.4 cm
Item Weight: 1.15 kg
Number of Pages: 502 Pages
Publication Name: Cell Therapy: Cgmp Facilities and Manufacturing
Language: English
Publisher: Springer Nature Switzerland A&G
Item Height: 235 mm
Subject: Medicine, Biology, Management
Publication Year: 2021
Type: Textbook
Author: Adrian P. Gee
Item Width: 155 mm
Format: Hardcover