Buch, Englisch, 372 Seiten, Format (B × H): 157 mm x 235 mm, Gewicht: 692 g
From Proof-of-Concept through Manufacturing to Commercialization
Buch, Englisch, 372 Seiten, Format (B × H): 157 mm x 235 mm, Gewicht: 692 g
ISBN: 978-1-032-25797-6
Verlag: CRC Press
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.
Zielgruppe
Academic, Postgraduate, Professional, and Undergraduate Advanced
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
- Naturwissenschaften Biowissenschaften Molekularbiologie
- Naturwissenschaften Chemie Chemie Allgemein
- Naturwissenschaften Biowissenschaften Biowissenschaften Genetik und Genomik (nichtmedizinisch)
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
Weitere Infos & Material
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
