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Cell Therapy

cGMP Facilities and Manufacturing

Editors: Gee, Adrian (Ed.)

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eBook $119.00
price for USA in USD (gross)
  • ISBN 978-0-387-89584-0
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $169.99
price for USA in USD
  • ISBN 978-0-387-89583-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $159.99
price for USA in USD
  • ISBN 978-1-4614-9793-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

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).

Table of contents (19 chapters)

  • Regulation of Cell Product Manufacturing and Delivery: A United States Perspective

    Lindblad, R.W., MD, FACEP

    Pages 3-25

  • The Regulatory Situation for Academic Cell Therapy Facilities in Europe

    Slaper-Cortenbach, I., PhD (et al.)

    Pages 27-35

  • A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia

    Farrugia, A., BSc, PhD

    Pages 37-48

  • University of Minnesota - Molecular and Cellular Therapeutics (MCT)

    McKenna, D.H., Jr, MD

    Pages 51-56

  • University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL)

    Griffin, D.L., MS (et al.)

    Pages 57-65

Buy this book

eBook $119.00
price for USA in USD (gross)
  • ISBN 978-0-387-89584-0
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $169.99
price for USA in USD
  • ISBN 978-0-387-89583-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $159.99
price for USA in USD
  • ISBN 978-1-4614-9793-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Cell Therapy
Book Subtitle
cGMP Facilities and Manufacturing
Editors
  • Adrian Gee
Copyright
2009
Publisher
Springer US
Copyright Holder
Springer-Verlag US
eBook ISBN
978-0-387-89584-0
DOI
10.1007/b102110
Hardcover ISBN
978-0-387-89583-3
Softcover ISBN
978-1-4614-9793-6
Edition Number
1
Number of Pages
XX, 256
Topics