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Essential requirements for setting up a stem cell processing laboratory

Bone Marrow Transplantation volume 49, pages 1098–1105 (2014)Cite this article

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Abstract

The Graft Processing subcommittee of the Worldwide Network for Blood and Marrow Transplantation wrote this guideline to assist physicians and laboratory technologists with the setting up of a cell processing laboratory (CPL) to support a hematopoietic stem cell transplant program, thereby facilitating the start-up of a transplant program in a new location and improving patient access to transplantation worldwide. This guideline describes the minimal essential features of designing such a laboratory and provides a list of equipment and supply needs and staffing recommendations. It describes the typical scope of services that a CPL is expected to perform, including product testing services, and discusses the basic principles behind the most frequent procedures. Quality management (QM) principles specific to a CPL are also discussed. References to additional guidance documents that are available worldwide to assist with QM and regulatory compliance are also provided.

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Authors and Affiliations

  1. Hoxworth Blood Center, University of Cincinnati Academic Health Center, Cincinnati, OH, USA

    T Leemhuis

  2. Human Cellular Therapy Laboratory Mayo Clinic, Rochester, MN, USA

    D Padley

  3. Department of Medicine, Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA

    C Keever-Taylor

  4. Division of Hematology and Medical Oncology, University of Leipzig, Johannisallee 32A, Leipzig, Germany

    D Niederwieser

  5. Department of Hematology, Hokkaido University Graduate School of Medicine, Sapporo, Japan

    T Teshima

  6. Section of Hematology & BMT unit, Hospital of Cremona, Cremona, Italy

    F Lanza

  7. Institut Paoli-Calmettes & Inserm CBT-510, Marseilles, France

    C Chabannon

  8. Division of Blood and Marrow Transplantation and Cellular Therapies Children's Hospital of Pittsburgh of UPMC, One Children's Hospital Drive, Pittsburgh, PA, USA

    P Szabolcs

  9. Department of internal Medicine and BMT program, American University of Beirut Medical Center, Beirut, Lebanon

    A Bazarbachi

  10. Stem Cell Transplant Programme, St George’s Hospital and Medical School, London, UK

    M B C Koh

  11. Blood Services Group, Health Sciences Authority, Outram Road, Singapore

    M B C Koh

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  1. T Leemhuis
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  2. D Padley
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  3. C Keever-Taylor
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  4. D Niederwieser
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  5. T Teshima
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  6. F Lanza
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on behalf of the Graft Processing Subcommittee of the Worldwide Network for Blood and Bone Marrow Transplantation (WBMT)

Corresponding author

Correspondence to M B C Koh.

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Leemhuis, T., Padley, D., Keever-Taylor, C. et al. Essential requirements for setting up a stem cell processing laboratory. Bone Marrow Transplant 49, 1098–1105 (2014). https://doi.org/10.1038/bmt.2014.104

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  • DOI: https://doi.org/10.1038/bmt.2014.104

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