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Cell Therapy

cGMP Facilities and Manufacturing

  • Book
  • © 2022

Overview

Editors:
  1. Adrian P. Gee

    1. Texas Children’s Cancer Center, Center for Cell and Gene Therapy, Houston, USA

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  • Fully updated and expanded second edition reflects all recent developments and changes in the field

  • Comprehensive coverage of essential information from ethical considerations and facility management to product tracing and labeling, staff training and much more

  • Covers other essential topics like quality management, professional standards, writing/maintaining Standard Operating Procedures, financial considerations for academic facilities, future directions, etc

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Table of contents (42 chapters)

  1. Front Matter

    Pages i-x
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  2. Regulatory

    1. Front Matter

      Pages 1-1
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    2. Regulation of Cellular Therapy in the United States

      • Nicole Fisher, Laarni Ibenana, Ashraf El Fiky, Robert Anderson
      Pages 3-40

    3. Regulatory Landscape and Emerging Trends in Advanced Therapy Manufacturing: An EU Perspective

      • Mohamed Abou-el-Enein
      Pages 41-55

    4. Australian Cellular Therapy Regulations

      • Rosemarie Bell
      Pages 57-71

    5. Landscape for Regenerative Medicine Manufacturing in Japan

      • Ryu Yanagisawa, Yozo Nakazawa
      Pages 73-79

    6. GLP Regulations for Nonclinical Studies

      • Aisha Khan, Yee-Shuan Lee, Joshua M. Hare
      Pages 81-99

    7. Ethical Considerations in Cell Therapy

      • Erica C. Jonlin
      Pages 101-118

    8. Investigational New Drug Applications for Cell Therapy Products

      • Bambi Grilley
      Pages 119-143

    9. FDA Inspections

      • Adrian P. Gee
      Pages 145-160

    10. Commercialization of Investigational Cell Therapy Products

      • Aimaz Afrough, Helen E. Heslop, LaQuisa C. Hill
      Pages 161-178

  3. Quality Systems

    1. Front Matter

      Pages 179-179
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    2. The Meaning of Quality

      • J. Wade Atkins
      Pages 181-193

    3. Development and Maintenance of a Quality Program

      • Adrian P. Gee
      Pages 195-208

    4. Quality Control of Cellular Therapy Products and Viral Vectors

      • Adrian P. Gee
      Pages 209-223

    5. Quality Management Software: Q-Pulse

      • Natalia Lapteva
      Pages 225-234

    6. Selection of Contract Manufacturing and Testing Organizations

      • Adrian P. Gee, Deborah Lyon
      Pages 235-243

  4. Facility Design

    1. Front Matter

      Pages 245-245
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    2. Introduction: Facility Design

      • Adrian P. Gee
      Pages 247-255

    3. Design and Operation of a Multiuse GMP Facility at the City of Hope

      • Larry Couture, David Hsu, Yasmine Shad, Mihir Vashi, Rajiv Nallu, Joseph Gold
      Pages 257-269
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Keywords

About this book

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. 

Editors and Affiliations

  • Texas Children’s Cancer Center, Center for Cell and Gene Therapy, Houston, USA

    Adrian P. Gee

About the editor

Dr. Adrian Gee is currently Professor of Medicine & Pediatrics, Center for Cell & Gene Therapy at Baylor College of Medicine. He received his bachelor’s degree from the University of Birmingham, England, and his Ph.D. from the University of Edinburgh, Scotland. He completed postdoctoral training at the National Institutes of Health and the University of Toronto. He then joined the faculty at the University of Florida where he performed some of the first applications of immunomagnetic tumor purging in the United States, and his laboratory became a central cell processing facility for this procedure. He co-founded the International Society for Hematotherapy and Graft Engineering (ISHAGE, now ISCT), and the Journal of Hematotherapy (now Cytotherapy) and helped establish the stem cell transplantation program at the University of South Carolina. He then directed the Cell Processing Laboratory at the University of Texas MD Anderson Cancer Center until he joined the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine in Houston. The CAGT houses GMP manufacturing facilities for vectors and cell therapy products, and has been selected as one of the 5 national somatic cell therapy processing centers by the National Heart, Lung & Blood Institute. Dr. Gee was involved in the development of standards for the collection processing and transplantation of hematopoietic stem cells for the Foundation for the Accreditation of Cell Therapy (FACT), the American Association of Blood Banks and the National Marrow Donor Program.

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