Cell Therapy cGMP Facilities and Manufacturing 2nd Edition by Adrian P Gee 9783030755379 3030755371

Cell Therapy cGMP Facilities and Manufacturing 2nd Edition Adrian P Gee – Ebook PDF Instant Download/Delivery ISBN(s): 9783030755379, 3030755371

Product details:

• ISBN 10: 3030755371
• ISBN 13: 9783030755379
• Author: Adrian P Gee

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.

Table contents:

Part I. Regulatory

Part II. Quality Systems

Part III. Facility Design

Part IV. Facility Infrastructure

Part V. Product Management

Part VI. Professional Standards and Support Organizations

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