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Handbook of Cell and Gene Therapy: From Proof-of-Concept through Manufacturing to Commercialization

SKU: 9781032257976

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A comprehensive guide covering the entire lifecycle of cell and gene therapy development, from initial proof-of-concept through manufacturing scale-up to successful commercialization. This handbook provides essential insights for researchers, clinicians, and industry professionals involved in bringing these transformative therapies to market.

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Description

The Handbook of Cell and Gene Therapy is an authoritative resource that traces the complete journey of therapeutic development in this rapidly evolving field. Written by industry experts Hazel Aranha and Humberto Vega-Mercado, this CRC Press publication addresses the critical stages of bringing cell and gene therapies from laboratory validation to commercial success.

The handbook covers essential topics including proof-of-concept studies, preclinical and clinical development strategies, regulatory pathways, manufacturing processes, quality control, and commercialization strategies. It provides practical guidance on navigating complex regulatory requirements, optimizing production scalability, and addressing the unique challenges posed by advanced therapeutic modalities.

Ideal for biotech professionals, pharmaceutical companies, researchers, and healthcare innovators, this comprehensive guide bridges the gap between scientific discovery and market-ready therapies, offering real-world perspectives and best practices for successful therapy commercialization.

Additional information

Author

Hazel Aranha, Humberto Vega-Mercado

Publisher

‏ : ‎ CRC Press

ISBN

9781032257976

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