Cell Therapy: cGMP Facilities and Manufacturing 2009th ED

Book Reviews: The use of cell-based therapies is currently undergoing a rebirth, based upon the extraordinary ability of pluripotent stem cells to differentiate into every other type of cell. This opens up almost unlimited applications in tissue regeneration and repair. It is important to remember, however, that cellular therapies have a relatively long history, peppered with promises, some successes, and many disappointments. Over the years, the interest has, as a result, waxed and waned, but there has been undoubted forward momentum, which has brought us to this important point. This progress has been made possible by work in many disciplines, including immunology, cell and molecular biology, hematology, and clinical medicine. A somewhat overlooked, but critical area has been the work of the cell processing or manufacturing technologists and researchers. These individuals are the true translational scientists. They have bridged that often-quoted gulf between “bench and bedside.” This was, and continues to be, pioneering work, since it required development of many of the tools and techniques that today we take for granted. Many of us have memories of times when the field seemed more like alchemy than science! It has been exciting and rewarding to see it grow and mature and to have the opportunity to work with and learn from colleagues with so many different perspectives. All of us have benefited from the experience of biologists and engineers, blood bankers and physicians, and even regulators and lawyers. If we are to succeed in this next important phase, that kind of interaction must be continued and strengthened.

An important change is occurring in the way we work. The area is now sufficiently mature that it is no longer acceptable to operate as an outgrowth of an academic research laboratory. We are now a stand-alone discipline with both expertise and responsibilities. This transition has occurred relatively rapidly and was necessitated by developments both in science and in regulation. We have the obligation to make possible these new therapies in the context of offering the recipient a safe and hopefully effective product.

There have been few resources to call upon to help us, apart from the support network that has grown between facilities and individuals. Initially this took the form of reassuring each other that we were operating in similar ways, now we need to build upon this foundation.

This book is an attempt to provide a written guide to how academic cell therapy product manufacturing facilities (usually referred to as Good Manufacturing

Practice (GMP) facilities) operate. The aim is to share the common experience of individuals who have worked in the field. It has its origins in the contract facilities of the original Production Assistance for Cellular Therapies (PACT) group – at Universities of Minnesota and Pittsburgh and Baylor College of Medicine. These centers worked under a contract from the U.S. National Heart, Lung, and Blood Institute (NHLBI) to provide cell product manufacturing services to clinical centers around the country. The contract also included administrative and coordinating services

provided by the EMMES Corporation in Maryland. For this endeavor to succeed it was important to develop close communication between the centers, not only in relation to providing products, but also to achieve the additional goal of educational outreach to the community as a whole. These interactions resulted in collaborative studies, training courses, and webinars, and stimulated the development of this book.

Bibliographical Data of Cell Therapy: cGMP Facilities and Manufacturing 2009th ED

Reference Type: Book
Record Number: xx
Author: Adrian Gee
Year: 2009
Place Published: New York City
Publisher: Springer
Number of Pages: 256
Edition: 2009
ISBN -10: 0387895833
ISBN-13: 978-0387895833
Kindle Available: ASIN: B01K0SHKDQ
Buy: Get it on Amazon

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