Overview

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. 

Full Product Details

Author:   Adrian P. Gee
Publisher:   Springer Nature Switzerland AG
Imprint:   Springer Nature Switzerland AG
Edition:   2nd ed. 2022
Weight:   1.226kg
ISBN:  

9783030755355

ISBN 10:   3030755355
Pages:   692
Publication Date:   11 November 2021
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand  
We will order this item for you from a manufactured on demand supplier.

Table of Contents

Part 1.     Regulatory1.  Regulation of Cell Therapy in the United States  2.   Regulatory Landscape and Emerging Trends In Advanced Therapies Manufacturing: An EU Perspective  3.   Australian Cellular Therapy Regulations  4.   Landscape for Regenerative Medicine Manufacturing in Japan  5.   GLP Regulations for Non-clinical studies  6.  Ethical Considerations in Cell Therapy  7.  Investigational New Drug Applications for Cell Therapy Products 8.   FDA Inspections  9.   Commercialization of Investigational Cell Therapy Products  Part 2   Quality Systems 10.  The Meaning of Quality  11.   Development and Maintenance of a Quality Program 12.   Quality Control of Cellular Therapy Products and Viral Vectors  13.   Quality Management Software – Q-Pulse  14.   Selection of Contract Manufacturing and Testing Organizations  Part 3     Facility Design 15.   Introduction: Facility Design  16.   PACT CPFs - Examples Describing Different Cell Processing Facility Designs 17. Design and Operation of a Multiuse GMP Facility at the City of Hope  18. Design and Operation of a Multiuse GMP Facility at the University of Miami  19.   Design of a New Academic GMP Facility for Today and Beyond at the Dana-Farber Cancer Institute 20.  Design and Licensure of an American Cord Blood Bank  21.   Indiana University Vector Production Facility (IUVPF)  22.   Qualification and Commissioning of a New GMP Facility  Part 4    Facility Infrastructure 23.   Environmental Monitoring  24.   GMP Facility Cleaning and Maintenance  25.  GMP Documentation  26.   Process Validation  27.   Equipment Qualification  28.  Vendor Qualification and Supply Management  29.  Staffing, Training and Competency  Part 5    Product Management 30.   Product Accessioning, Tracing and Tracking  31.   ISBT 128 in Labeling of Cellular Therapy Products  32.   Product Processing, Manufacturing and Administration  33.   Transport and Shipment of Cellular and Gene Therapy Products  34.    Regenerative Medicine: The Newest Cellular Therapy 35.     Cellular Therapy Applications for COVID-19  Part 6    Professional Standards and Support Organizations 36.   Professional Standards for Cellular Therapy: The Foundation for the Accreditation of Cellular Therapy (FACT)  37.   AABB Cell Therapy Standards 38.  USP Standards for Cell-based Therapies 39.   The Role of the National Institute of Standards Measurement Assurance for Cell Therapies 40.  National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT)  41.  Financial Considerations for Academic GMP Facilities  42.  Governmental Support Opportunities for Cellular & Gene Therapies in the United States 

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Author Information

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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