Handbook of Cell and Gene Therapy (eBook, PDF)

From Proof-of-Concept through Manufacturing to Commercialization
Redaktion: Aranha, Hazel; Vega-Mercado, Humberto

• Format: PDF

Produktbeschreibung

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.

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Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 372
• Erscheinungstermin: 17. März 2023
• Englisch
• ISBN-13: 9781000864205
• Artikelnr.: 67419416

Inhaltsangabe

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