Cell Therapy: cGMP Facilities and Manufacturing

2009 | 256 Pages | ISBN: 0387895833 | PDF | 9 MB

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 proceduresSupply managementFacility equipmentProduct manufacturing, review, release and administrationFacility master fileThis 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).

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