Cell Therapy: cGMP Facilities and Manufacturing
Springer Science & Business Media, Sep 18, 2009 - Science - 256 pages
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.
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University of Minnesota Molecular and Cellular
Baylor College of Medicine Center for Cell
AABB Cell Therapy Standards
Standard Operating Procedures
Product Review Release and Administration
Use of a Facility Master File to Facilitate Regulatory