vbid/9783030755379

Description

This new edition presents a fully-updated and expanded look at�current Good Manufacturing Practice (cGMP) for�cell therapy products. It provides a complete discussion of�facility design and operation including details specific to�cord blood banking, cell processing, vector production and qualification of�a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The�detailed and invaluable product information covers topics like�labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like�writing and maintaining investigational new drug applications, support opportunities in North America and the�European Union, commercial cell processing and quality testing services, and financial considerations for�academic GMP facilities. A�chapter on�future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for�any cell therapy professional involved in the�development, use, or management of�this type of�facility.�Typham this is the title: Cell Therapy cGMP Facilities and Manufacturing 2nd Edition