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

ISBN-13: 9781032257976 / Angielski / Twarda / 2023 / 312 str.

Aranha, Hazel

Opis

This book is intended as a one-stop resource for availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions working in the field.

Recenzje

Just spreading the exciting news: Humberto Vega, one of the pharmaceutical industry's icon's in the cell and gene therapy space, recently released a book that describes a soup-to-nuts approach to commercialization of cell and gene therapies. It is rare to find any publications in this area that are this comprehensive and cover activities spanning from the early development phase all the way to commercialization. The book is written for a diverse audience that ranges from researchers, scientists and management to academic and research institutions--basically anyone involved in the support of the core technologies and supportive practices in this space. It is widely available for purchase on Amazon, Barnes and Noble, Routledge and many other sources. Congratulations to Humberto Vega　and HAZEL ARANHA!

- Brian Kirk

The cell and gene therapies industry is growing rapidly. The "Handbook of Cell and Gene Therapy" is fresh off the presses and contains the latest details on the development, production, and delivery of life-saving cell and gene therapy materials. Co-editor Hazel Aranha, PhD, knows her stuff! Because I edit scientific bioprocessing papers from researchers and commercial production people, I need to stay on top of my knowledge base. This handbook will help me significantly. I am happy to own the book -- as of March 26, 2023 -- and have already started reading it.

- Marcie Brown

Spis treści

History of Gene Therapy Products; Overview of technologies applied to gene therapy products; History of Cell Therapy Products; Overview of technologies applied to cell therapy products – what it entails; Gene Therapy Manufacturing- an Overview on Viral Vectors and Plasmid Manufacturing, Does it suffice; Basic considerations – Manufacturing Processes: - Cell therapy products; Analytical Methods; Facility and equipment considerations; Control of adventitious agent contamination during manufacture of cell and gene therapy products; Quality Considerations from Clinical to Commercial Manufacturing; Regulatory Compliance and Approval; CMC Submissions; Validation, Verification and Qualification Considerations; Clinical development of cell and gene therapies –from first-in-human to postmarketing studies; Risk-based approach in the development of cell and gene therapy products; Current global regulatory landscape; Comparison of EU and US Regulatory Requirements; Regulatory Landscape for Gene and Cell Therapies; Canada; China; Regulation of cell product and gene therapy; South Asia Countries; Japan; Regulatory Pathway for Cell, Tissue and Gene Therapy Products in Singapore; Regulatory Pathway for Cell and Gene Therapy Products in Malaysia; The Regulation of Cell and Gene Therapy Products in Australia and New Zealand; Pricing and market access: the market access hurdle; Training Approaches to Build Cell and Gene Therapy Workforce Capacity; Lessons Learned – Successes and Pitfalls; Pitfall Avoidance through Cross-Functional Development Approach