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Book
Cell therapy : cGMP facilities and manufacturing
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ISBN: 3030755371 3030755355 Year: 2021 Publisher: Cham, Switzerland : Springer International Publishing,

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Book
Cell Therapy
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ISBN: 9783030755379 9783030755355 9783030755362 Year: 2022 Publisher: Cham Springer International Publishing :Imprint: Springer

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Cell Therapy
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ISBN: 9783030755379 9783030755355 9783030755362 Year: 2022 Publisher: Cham Springer International Publishing :Imprint: Springer

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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. .

Advances in bone marrow purging and processing : fourth International symposium
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ISBN: 0471014532 Year: 1994 Publisher: New York, NY : Wiley-Liss,

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Bone marrow purging and processing : proceedings of the second international symposium on bone marrow purging and processing, held in Cancun, April 27 and 28, 1989

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