Adrian P. Gee - Cell Therapy: cGMP Facilities and Manufacturing

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Cellular and gene therapies are now producing very promising results and even potential cures. This has resulted in a dramatic increase in the number of academic institutions and biotechnology companies involved in the field. Many of these are engaged in conducting early phase clinical trials, which necessitates the use of facilities that comply with current Good Manufacturing Practices (cGMP) to prepare the therapeutic products. For those new to these regulations, it can be intimidating knowing how to start to design, build and run a cGMP-compliant facility. The purpose of this book is to update our original publication Cellular Therapy: cGMP Facilities and Manufacturing published in 2009. This book grew out of the Production Assistance for Cellular Therapy (PACT) contract program supported by the National Heart Lung and Blood Institute (NHLBI) of the U.S. National Institutes of Health. The second volume is also supported by the NHLBI and marks the termination of the third version of PACT.

In this updated and expanded volume, we provide basic advice to those manufacturing products for early phase clinical trials on the approaches used by a variety of facilities and individuals to comply with the regulations. This information is primarily intended for academic facilities and smaller or start-up biotechnology firms. It covers international governmental regulations for cellular therapies, the design and qualification of new facilities, operational activities, such as cleaning, environmental monitoring, equipment qualification, validation and document generation and management. It also discusses the roles played by professional accreditation organizations, standards and governmental agencies and funding organizations.

Our aim is to provide a repository of information that can be easily accessed and a listing of individuals whom the reader can contact to discuss the topics covered. Since much of the information contained is based upon governmental regulations it is strongly suggested that the reader keep abreast of current requirements whenever implementing any of the suggestions in this volume.

The editor would like to thank all of the authors for their contributions, especially during the time of the COVID-19 pandemic! They were all a joy to work with and simplified my task enormously. I would especially like to thank Laarni Ibenana and Lisa Davis of Emmes for their help in manuscript management and organization and Lis Welniak of NHLBI for her support of the book. My gratitude is also owed to all my colleagues at the Baylor College of Medicine Center for Cell and Gene Therapy in Houston for their help and encouragement.

As I near retirement, I should like to dedicate this volume to all those with whom I have had the pleasure of working and collaborating over the last 40 years. They have made my time in this area both enjoyable and stimulating. It has been incredible to see the evolution of these new treatments and I shall continue to monitor their progress with fascination.