Edited by David McKenna Jr, MD, CABP(H)(AABB), and David Stroncek, MD

This manual was designed as a compendium of state-of-the-art practices for developing and producing cellular and biotherapy products. It will be useful in the development and operation of facilities that are entering and thriving in this fast-paced field, whether for research, translational, or clinical operations. 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 requirements and common practices in 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, the chapters and appendices provide information on the critical steps, materials, and equipment used in various processes.