Cell Therapy : cGMP Facilities and Manufacturing
Language: English
Published by Springer, 2021
- Hardcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 205.60
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Add to basketItem description from seller
Druck auf Anfrage Neuware - Printed after ordering - This new edition presents a fully-updated and expanded look atcurrent Good Manufacturing Practice (cGMP) forcell therapy products. It provides a complete discussion offacility design and operation including details specific tocord blood banking, cell processing, vector production and qualification ofa new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. Thedetailed and invaluable product information covers topics likelabelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics likewriting and maintaining investigational new drug applications, support opportunities in North America and theEuropean Union, commercial cell processing and quality testing services, and financial considerations foracademic GMP facilities. Achapter onfuture directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading forany cell therapy professional involved in thedevelopment, use, or management ofthis type offacility.…
Seller Inventory # 9783030755355
- Title
- Cell Therapy : cGMP Facilities and Manufacturing
- Author
- Adrian P. Gee
- Publisher
- Springer
- Publication year
- 2021
- Condition
- Neu
- Binding
- Buch
- Language
- English
- ISBN 10
- 3030755355
- ISBN 13
- 9783030755355
- Edition
- 2nd Edition
- Item weight
- 1,221 grams
- Dimensions
- 241x160x44 mm
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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