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    Cell Therapy (Hardback) Edited by Adrian P. Gee

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    DescriptionCell 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.


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    Title
    Cell Therapy
    Authors and contributors
    Edited by Adrian P. Gee
    Physical properties
    Format: Hardback
    Number of pages: 276
    Width: 155 mm
    Height: 235 mm
    Thickness: 23 mm
    Weight: 629 g
    Language
    English
    ISBN
    ISBN 13: 9780387895833
    ISBN 10: 0387895833
    Classifications

    BIC E4L: HEA
    B&T Book Type: NF
    Nielsen BookScan Product Class 3: S6.2
    LC subject heading:
    Ingram Subject Code: SE
    B&T General Subject: 510
    B&T Modifier: Region of Publication: 04
    BISAC V2.8: SCI029000
    Abridged Dewey: 616
    B&T Merchandise Category: MAJ
    B&T Modifier: Academic Level: 03
    B&T Modifier: Text Format: 06
    LC subject heading:
    BISAC V2.8: SCI049000
    BIC subject category V2: MFN
    Warengruppen-Systematik des deutschen Buchhandels: 16930
    LC subject heading:
    BISAC V2.8: MED107000, SCI017000
    DC22: 615.36
    Libri: ZELL4000
    BIC subject category V2: MJZ
    DC22: 615.895
    Libri: THER1000
    LC classification: RM301.37 .C455 2009
    LC subject heading: , , , , , , ,
    LC classification: QH301-705, QH573-671
    Thema V1.0: PSD, MFN, MKZV
    Edition
    1
    Illustrations note
    51 black & white illustrations, 11 colour illustrations, 18 black & white tables
    Publisher
    Springer-Verlag New York Inc.
    Imprint name
    Springer-Verlag New York Inc.
    Publication date
    01 November 2010
    Publication City/Country
    New York, NY
    Back cover copy
    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
    Preface List of Contributors List of Acronyms Part I. Regulatory Chapter 1. Regulation of Cell Product Manufacturing and Delivery: A United States Perspective Chapter 2. The Regulatory Situation for Academic Cell Therapy Facilities in Europe Chapter 3. A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia Part II. GMP Facility Design Chapter 4. University of Minnesota - Molecular and Cellular Therapeutics (MCT) Chapter 5. University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/ Immunological Monitoring and Cellular Products Laboratory (IMCPL) Chapter 6. Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT) Chapter 7. Design of a New GMP Facility - Lessons Learned Part III. Professional Cell Therapy Standards Chapter 8. AABB Cell Therapy Standards Chapter 9. Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT) Part IV. Facility Operations Chapter 10. Standard Operating Procedures Chapter 11. Staffing, Training, and Competency Chapter 12. Cleaning Procedures Chapter 13. Environmental Monitoring Chapter 14. Supply Management Chapter 15. Facility Equipment Chapter 16. Quality Chapter 17. Product Manufacturing Chapter 18. Product Review, Release, and Administration Chapter 19. Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products