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Cell Therapy: cGMP Facilities and Manufacturing
Edited by Adrian Gee, MIBiol, PhD

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.

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). 

(2009, 256 p. 62 illus., 11 in color., Hardcover)
ISBN: 978-0-387-89583-3
eBook: $149 - Hardcover $189

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Standards for Cellular Therapy Services, 7th edition  

The seventh edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.
Significant changes to the 7th edition include:

• Donor and patient informed consent requirements have been separated to provide more focused standards; this includes the expansion of Reference Standards 4.5A and 4.7A.
• Enhanced Chapter 5 Process Control to divide the chapter into four distinct areas of focus: general process control, procurement activities, processing activities, and clinical activities.
• New standards requiring specific time intervals depending on the nature of storage devices have been added in Standards 5.10.3.1 and 5.10.3.2.
• Standards relating to in-utero and ex-utero cord blood collections have been added to the 7th edition to assist users as it relates to product labeling.
• Donor evaluation standards focused on clinical activities have been added to this edition in Standards 5.24.1 – 5.24.1.2.

(2015, AABB, softcover, 154 pages)

Core Principles in Cellular Therapy, 3rd edition 

This handy text provides a focused look at hematopoietic and nonhematopoietic cellular therapy that will be useful to those working on the periphery as well as the mainstream of this exciting field. Written by experts, these chapters excerpted from the AABB Technical Manual, 18th edition, were also peer-reviewed by AABB cellular therapy committee and subsection members. Together, these chapters capture what is essential to know about cellular therapy and regenerative medicine—for example, new advances in induced pluripotent stem cells, mesenchymal stem cells, adipose-derived stem cells— as well as more established cellular therapy products.

(AABB, 2014, ISBN# 978-1-56395-892-2) 

Product Code: 143030
List Price: $89
AABB Member Price: $59

Cellular Therapy: Principles, Methods, and Regulations, 2nd edition
Edited by Ellen M. Areman, MS, SBB(ASCP), and Kathy Loper, MHS, MT(ASCP) 

This manual was designed as a compendium of state-of-the-art practices and methods for developing and producing cellular therapy products, and for development and operation of a cellular therapy facility, whether for research, translational or clinical. Applicable to academia, government and industry, it is also an essential reference for those in regulatory affairs and quality assurance as well as for laboratory technologists, managers, directors, physicians and scientists. Through descriptions of the rationale and methodology for a variety of cell processing and evaluation techniques, it will assist laboratory staff in developing procedures that comply with applicable regulations and standards. In addition to numerous examples and templates for laboratory document preparation, several methods are provided that include a general overview of the critical steps, materials and equipment used in each process. Each section has been compiled and edited by a team of experts in the field, with subchapters contributed by specialists in the specific subject matter. As regenerative medicine becomes more integrated into the field, considerations for regenerative therapies are also integrated within each section.

(AABB, 2016, hard cover, 897 pages, ISBN# 978-1-56395-916-5) 

Product Code: 153420 
List Price: $225
AABB Member Price: $195
 

Hematopoietic Stem Cell Transplantation: A Handbook for Clinicians, 2nd edition

This second edition of Hematopoietic Stem Cell Transplantation: A Handbook for Clinicians (HSCT) offers comprehensive and practical information for healthcare providers working in the HSCT field. It provides relevant information on all areas of HSCT, including indications for transplantation; donor and patient evaluation; conditioning regimens; collection, processing, and characterization of stem cell products; management of immunosuppressive therapy; evaluation and management of the most common complications during HSCT; supportive care management; common procedures; and aspects of follow-up care. The emphasis of the Handbook is placed on providing up-to-date information in a clinically meaningful way.

This edition’s content has been reorganized to facilitate finding topics of interest more easily and the authors emphasized an educational bent in presenting their material. Each of the topics in the first edition has been revised to ensure the content is up to date. New chapters covering nonmalignant diseases, haploidentical transplants, photopheresis, financial considerations, and iron overload have been added.

(AABB, 2015, ISBN#978-1-56395-876-2) 

Product Code: 143425
List Price: $192
AABB Member Price: $156