Cell Therapy: Cgmp Facilities and Manufacturing

Gee, Adrian P.

商品描述

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.

作者簡介

Dr. Adrian Gee is currently Professor of Medicine & Pediatrics, Center for Cell & Gene Therapy at Baylor College of Medicine. He received his bachelor's degree from the University of Birmingham, England, and his Ph.D. from the University of Edinburgh, Scotland. He completed postdoctoral training at the National Institutes of Health and the University of Toronto. He then joined the faculty at the University of Florida where he performed some of the first applications of immunomagnetic tumor purging in the United States, and his laboratory became a central cell processing facility for this procedure. He co-founded the International Society for Hematotherapy and Graft Engineering (ISHAGE, now ISCT), and the Journal of Hematotherapy (now Cytotherapy) and helped establish the stem cell transplantation program at the University of South Carolina. He then directed the Cell Processing Laboratory at the University of Texas MD Anderson Cancer Center until he joined the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine in Houston. The CAGT houses GMP manufacturing facilities for vectors and cell therapy products, and has been selected as one of the 5 national somatic cell therapy processing centers by the National Heart, Lung & Blood Institute. Dr. Gee was involved in the development of standards for the collection processing and transplantation of hematopoietic stem cells for the Foundation for the Accreditation of Cell Therapy (FACT), the American Association of Blood Banks and the National Marrow Donor Program.