Cell Therapy (eBook)

cGMP Facilities and Manufacturing

Adrian P. Gee (Herausgeber)

eBook Download: PDF

2021 | 2. Auflage
X, 692 Seiten
Springer-Verlag
978-3-030-75537-9 (ISBN)

Infos

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. 

Produkt-Details

• Erscheint lt. Verlag: 10.11.2021
• Zusatzinfo: X, 692 p. 107 illus., 75 illus. in color.
• Sprache: englisch
• Themenwelt: Naturwissenschaften ► Biologie ► Mikrobiologie / Immunologie
• Themenwelt: Wirtschaft
• Schlagworte: cell processing facilities • cell product manufacturing • cell therapy standards • Cellular Therapy Applications for COVID-19 • Design and Operation of a Multiuse GMP Facility • ethical considerations in cell therapy • New Drug Applications for Cell Therapy Products • Quality Control of Cellular Therapy Products • Regenerative medicine • regulation of cell therapy
• ISBN-10: 3-030-75537-1 / 3030755371
• ISBN-13: 978-3-030-75537-9 / 9783030755379