from proof-of-concept through manufacturing to commercialization Aranha, Hazel creator Vega-Mercado, Humberto editor. text nyu New York CRC Press c2023 2023 First edition. monographic eng

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xxi, 349 p. : ill., table ; 22 cm. "This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish as well as delivery options. Planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC) are also discussed. This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor"-- edited by Hazel Aranha, Humberto Vega-Mercado Includes bibliographical references and index. Cellular therapy Handbooks, manuals, etc Gene therapy Handbooks, manuals, etc Cellular therapy Research Handbooks, manuals, etc Gene therapy Research Handbooks, manuals, etc 615.895 ARH Boca Raton : CRC Press, 2023 First edition. (DLC) 2022050143 9781032257976 9781032257983 BD-ChVAS 260709 20260709125259.0 eng