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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 This 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).

Cellular therapy --- Drug factories --- Facility Regulation and Control --- Drug Industry --- Quality Control --- Cell Transplantation --- Technology --- Industry --- Quality Assurance, Health Care --- Transplantation --- Social Control, Formal --- Health Care Quality, Access, and Evaluation --- Surgical Procedures, Operative --- Technology, Industry, and Agriculture --- Health Care Economics and Organizations --- Health Care --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Technology, Industry, Agriculture --- Cytology --- Pharmacy, Therapeutics, & Pharmacology --- Biology --- Health & Biological Sciences --- Standards --- Quality control --- Cyclic guanylic acid. --- Cellular therapy. --- Cell therapy --- Cells --- Therapy, Cellular --- cGMP (Biochemical) --- Cyclic GMP --- Cyclic guanosine monophosphate --- Guanosine cyclic monophosphate --- Guanylic acid, Cyclic --- Therapeutic use --- Life sciences. --- Cell biology. --- Life Sciences. --- Cell Biology. --- Organotherapy --- Therapeutics, Physiological --- Transplantation of organs, tissues, etc. --- Cell transplantation --- Cyclic nucleotides --- Cytology. --- Cell biology --- Cellular biology --- Cytologists