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E-grāmata: Handbook of Cell and Gene Therapy: From Proof-of-Concept through Manufacturing to Commercialization [Taylor & Francis e-book]

Edited by , Edited by (GAEA Resources, Inc., USA)
  • Formāts: 350 pages, 46 Tables, black and white; 9 Line drawings, color; 5 Line drawings, black and white; 10 Halftones, color; 3 Halftones, black and white; 19 Illustrations, color; 8 Illustrations, black and white
  • Izdošanas datums: 17-Mar-2023
  • Izdevniecība: CRC Press
  • ISBN-13: 9781003285069
Citas grāmatas par šo tēmu:
  • Taylor & Francis e-book
  • Cena: 195,66 €*
  • * this price gives unlimited concurrent access for unlimited time
  • Standarta cena: 279,51 €
  • Ietaupiet 30%
Handbook of Cell and Gene Therapy: From Proof-of-Concept through Manufacturing to CommercializationPalielināt
  • Formāts: 350 pages, 46 Tables, black and white; 9 Line drawings, color; 5 Line drawings, black and white; 10 Halftones, color; 3 Halftones, black and white; 19 Illustrations, color; 8 Illustrations, black and white
  • Izdošanas datums: 17-Mar-2023
  • Izdevniecība: CRC Press
  • ISBN-13: 9781003285069
Citas grāmatas par šo tēmu:
Taylor & Francis e-booksMore info about Taylor & Francis e-books
Rokasgrāmatas mājas lapa: https://www.taylorfrancis.com/books/9781003285069

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.

Features

  • Provides the most up-to-date information on the development of gene therapy, from the technology involved to gene correction and genome editing
  • Discusses siRNA, mRNA, and plasmid manufacturing
  • Describes the importance of supplier-sponsor synergies on the path to commercialization
  • Written for a diverse audience with a large number of individuals in the core technologies and supportive practices

It 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.



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.

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
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