GMP Facilities for Clinical Cell Therapy Product Manufacturing: A Brief Review of Requirements and Design Considerations

  • Hamid Reza Aghayan
  • Babak Arjmand
  • Scott R. BurgerEmail author
Part of the Stem Cell Biology and Regenerative Medicine book series (STEMCELL)


The field of cell-based therapies is evolving quickly, and its potential for transformational new treatment modalities has generated great excitement in the scientific community. In the decade 2000–2010, for example, cell therapy products accounted for over 2700 clinical trials, for a broad range of clinical applications. A risk-based approach to regulation of cell therapy products has been widely adopted by regulatory agencies, to balance risks and potential benefits of these novel therapies. Good Manufacturing Practices (GMPs) are fundamental to product safety and quality. GMPs involve multiple elements covering all aspects of production, and although each element is equally important, the facility is the most obvious and tangible of these. This chapter summarizes basic requirements for cell therapy GMP facilities and provides an overview of facility planning and design, cleanroom classifications, and operating procedures.


Aseptic processing Cell therapy Cleanroom Facility GMP Manufacturing 


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Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Hamid Reza Aghayan
    • 1
  • Babak Arjmand
    • 2
    • 3
  • Scott R. Burger
    • 4
    Email author
  1. 1.Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences InstituteTehran University of Medical SciencesTehranIran
  2. 2.Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences InstituteTehran University of Medical SciencesTehranIran
  3. 3.Brain and Spinal Cord Injury Research CenterTehran University of Medical SciencesTehranIran
  4. 4.Advanced Cell & Gene Therapy, LLCChapel HillUSA

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