Overview

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.

Full Product Details

Author:   Adrian Gee
Publisher:   Springer-Verlag New York Inc.
Imprint:   Springer-Verlag New York Inc.
Edition:   2009 ed.
Dimensions:   Width: 15.50cm , Height: 2.30cm , Length: 23.50cm
Weight:   0.633kg
ISBN:  

9780387895833

ISBN 10:   0387895833
Pages:   256
Publication Date:   25 September 2009
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

I. Regulatory.- Regulation of Cell Product Manufacturing and Delivery: A United States Perspective.- The Regulatory Situation for Academic Cell Therapy Facilities in Europe.- A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia.- II. GMP Facility Design.- University of Minnesota - Molecular and Cellular Therapeutics (MCT).- University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL).- Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT).- Design of a New GMP Facility - Lessons Learned.- III. Professional Cell Therapy Standards.- AABB Cell Therapy Standards.- Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT).- IV. Facility Operations.- Standard Operating Procedures.- Staffing, Training, and Competency.- Cleaning Procedures.- Environmental Monitoring.- Supply Management.- Facility Equipment.- Quality.- Product Manufacturing.- Product Review, Release, and Administration.- Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products.

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