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Cell Therapy

cGMP Facilities and Manufacturing

  • Adrian Gee

Table of contents

  1. Front Matter
    Pages i-xx
  2. Part I. Regulatory

    1. Front Matter
      Pages 1-1
    2. I. Slaper-Cortenbach, M. Scott, D. Herrmann, M. Introna, K. Theunissen, P. Theocharous et al.
      Pages 27-35
  3. Part II. GMP Facility Design

  4. Part III. Professional Cell Therapy Standards

    1. Front Matter
      Pages 86-86
    2. Z.M. Szczepiorkowski, E. Nunes
      Pages 87-95
  5. Part IV. Facility Operations

    1. Front Matter
      Pages 108-108
    2. C.G. Lindgren
      Pages 109-120
    3. D.M. Kadidlo
      Pages 121-134
    4. A. Gee, D.L. Lyon
      Pages 135-144
    5. A. Gee, D.L. Lyon
      Pages 145-155
    6. A. Gee, C.M. Rooney
      Pages 157-170
    7. D.L. Griffin
      Pages 171-186
    8. J.W. Atkins
      Pages 187-197
    9. A. Gee
      Pages 199-213
    10. N.H. Collins
      Pages 215-228
  6. Back Matter
    Pages 237-256

About this book

Introduction

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.

Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…

  • Standard operating procedures
  • Supply management
  • Facility equipment
  • Product manufacturing, review, release and administration
  • Facility master file

This volume contains a collection of chapters authored by individuals who are active in the field of cell therapy product manufacturing. The collection and editing of these chapters was supported in part by the National Institutes of Health (National Heart, Lung and Blood Institute) program Production Assistance for Cellular Therapies (PACT).

Keywords

cancer cell gene gene therapy genes regulation research stem cell tissue

Editors and affiliations

  • Adrian Gee
    • 1
  1. 1.Baylor College of MedicineHoustonU.S.A.

Bibliographic information

Industry Sectors
Pharma
Biotechnology
Consumer Packaged Goods