Cell Therapy: cGMP Facilities and Manufacturing

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Adrian Gee
Springer Science & Business Media, Sep 18, 2009 - Science - 256 pages
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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
 

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Contents

Regulation of Cell Product Manufacturing
3
3
34
University of Minnesota Molecular and Cellular
51
6
59
Baylor College of Medicine Center for Cell
67
7
79
AABB Cell Therapy Standards
87
Standard Operating Procedures
109
Environmental Monitoring
145
Supply Management
157
Facility Equipment
171
Quality
187
Product Manufacturing
199
Product Review Release and Administration
215
Use of a Facility Master File to Facilitate Regulatory
229
Appendix A
237

Staffing Training and Competency
121
Cleaning Procedures
135

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