Cell Therapy Books
NHLBI PACT Supported:
Cell Therapy Book 2nd Edition
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Cell Therapy: cGMP Facilities and Manufacturing/2nd Edition/Coming Summer 2021
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| 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. |
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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). approx 300 pages |
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Second Edition Full Table of Contents:
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Part 1. Regulatory
Part 2 Quality Systems
Part 3 Facility Design
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Part 4 Facility Infrastructure
Part 5 Product Management
Part 6 Professional Standards and Support Organizations
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Cell Therapy Book 1st Edition
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Cell Therapy: cGMP Facilities and Manufacturing 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. |
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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) All book orders are to be processed through Springer Print and complete this form to order a copy via postal mail or fax. Mailing information is included in the form. |
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AABB Publications:
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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.
(2015, AABB, softcover, 154 pages) |
(AABB, 2014, ISBN# 978-1-56395-913-4)
List Price: $200
AABB Member Price: $175
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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. |
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(AABB, 2014, ISBN# 978-1-56395-892-2) Product Code: 143030 |
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Cellular Therapy: Principles, Methods, and Regulations, 2nd edition 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. |
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(AABB, 2016, hard cover, 897 pages, ISBN# 978-1-56395-916-5) Product Code: 153420 |
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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. |
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(AABB, 2015, ISBN#978-1-56395-876-2) Product Code: 143425
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Other Cell Therapy Publications of Interest
Circular of Information for Cellular Therapy Products September 2013
Immunology
Handbook of Human Immunology Second Edition By Maurice R. G. O'Gorman and Albert D. Donnenberg. 2008. CRC Press. Taylor and Francis Group (623 pages).
Cell Preservation
Advances in Biopreservation, ed. John G. Baust, CRC Press, Boca Raton, FL, USA, 2005.
This book covers a range of topics from preservation fundamentals to specific techniques. Systems studied include macromolecules, cells, and tissues (native and engineered). Life in the Frozen State, Ed. Fuller, B.J., Lane, N, Benson, E, CRC Press, London, 2004.
The preservation of cells, tissues, and gametes and supplemented by an extensive discussion of plant, bacteria, fungi preservation.
Clinical applications of Cryobiology, Ed. Fuller, B.J., Grout, B.W.W., CRC Press, Boca Raton, FL, USA, 1991.