Cell Therapy
cGMP Facilities and Manufacturing
Buch in deiner Nähe kaufen
Beschreibung
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.
Fully updated and expanded second edition reflects all recent developments and changes in the field
Comprehensive coverage of essential information from ethical considerations and facility management to product tracing and labeling, staff training and much more
Covers other essential topics like quality management, professional standards, writing/maintaining Standard Operating Procedures, financial considerations for academic facilities, future directions, etc.
Fully updated and expanded second edition reflects all recent developments and changes in the field Comprehensive coverage of essential information from ethical considerations and facility management to product tracing and labeling, staff training and much more Covers other essential topics like quality management, professional standards, writing/maintaining Standard Operating Procedures, financial considerations for academic facilities, future directions, etc
Autor*in
Adrian P. Gee
Themen in »Cell Therapy«
cell processing facilities cell product manufacturing cell therapy standards regulation of cell therapy ethical considerations in cell therapy Quality Control of Cellular Therapy Products regenerative medicine New Drug Applications for Cell Therapy Products Design and Operation of a Multiuse GMP Facility Cellular Therapy Applications for COVID-19