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.
Bone Marrow Processing and Purging: A Practical Guide provides an up-to-date practical guide to the major ex vivo procedures associated with bone marrow transplantation. Previously, this information was communicated primarily by word of mouth; now experts in the field present detailed descriptions and evaluations of methods for marrow harvesting, evaluation (including tumor infiltration, flow cytometric analysis, and colony assays), comparative methods for automated nucleated cell separation and enumeration, tumor cell purging, T cell depletion, stem cell selection, gene transfer, and cytopreservation. Special sections address quality control and FDA regulations. The book provides a unique information source intended for clinicians, researchers, technical staff, transplant nurses, and medical students involved in this rapidly expanding area of medicine.
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