Cell Therapy

This new edition presents a fully-updated and expanded look atcurrent Good Manufacturing Practice (cGMP) forcell therapy products. It provides a complete discussion offacility design and operation including details specific tocord blood banking, cell processing, vector production and qualification ofa new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. Thedetailed and invaluable product information covers topics likelabelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics likewriting and maintaining investigational new drug applications, support opportunities in North America and theEuropean Union, commercial cell processing and quality testing services, and financial considerations foracademic GMP facilities. Achapter onfuture directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading forany cell therapy professional involved in thedevelopment, use, or management ofthis type offacility.