Handbook of Cell and Gene Therapy

图书简介

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.FeaturesProvides the most up-to-date information on the development of gene therapy, from the technology involved to gene correction and genome editingDiscusses siRNA, mRNA, and plasmid manufacturingDescribes the importance of supplier-sponsor synergies on the path to commercializationWritten for a diverse audience with a large number of individuals in the core technologies and supportive practicesIt is intended as a one-stop resource for the availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions.

History of Gene Therapy Products Bridget Heelan Ethical Considerations on Cell and Gene Therapies Hazel Aranha Risk-based approach in the development of cell and gene therapy products Bridget Heelan Gene Therapy Products: Basics and manufacturing considerations Humberto Vega Cell therapy products: Basics and manufacturing considerations Humberto Vega Facility and Equipment Considerations Humberto Vega Analytical Methods for in-process testing and product reléase Neil A. Haig Validation, Verification and Qualification Considerations Humberto Vega Control of adventitious agent contamination during manufacture of cell and gene therapy products Hazel Aranha Training Approaches to Build Cell and Gene Therapy Workforce Capacity Orin Chisholm How to distribute Cell and Gene Therapies Andrea Zobel Regulatory Compliance and Approval Siegfried Schmitt (a) Regulatory Landscape in US, EU and Canada Kirsten Messmer (b) Regulatory Landscape in South America Heloisa Mizrahy (c) Regulatory Landscape in Australia and New Zealand Orin Chisholm 13 (d1) Regulatory Landscape in Singapure Stefanie Fasshauer 13 (d2) Regulatory Landscape in Malasya Stefanie Fasshauer 13 (e) Regulatory Landscape in China Kai Zhang 13 (f) Regulatory Landscape in Japan Hazel Aranha 13 (g) Regulatory Landscape in India Arun Bhatt 14. Lesson Learned - Success and Pitfalls

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Handbook of Cell and Gene Therapy 细胞与基因治疗手册：从概念验证到制造再到商业化 分子生物学

Handbook of Cell and Gene Therapy

细胞与基因治疗手册：从概念验证到制造再到商业化
分子生物学