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Beschreibung
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.
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.
Inhaltsverzeichnis
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
Details
Fachbereich: | Allgemeine Lexika |
---|---|
Genre: | Medizin |
Rubrik: | Wissenschaften |
Medium: | Buch |
Seiten: | 350 |
Inhalt: | Einband - fest (Hardcover) |
ISBN-13: | 9781032257976 |
ISBN-10: | 1032257970 |
Sprache: | Englisch |
Einband: | Gebunden |
Redaktion: |
Aranha, Hazel
Vega-Mercado, Humberto |
Hersteller: | Taylor & Francis Ltd |
Maße: | 230 x 157 x 25 mm |
Von/Mit: | Hazel Aranha (u. a.) |
Erscheinungsdatum: | 17.03.2023 |
Gewicht: | 0,636 kg |
Inhaltsverzeichnis
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
Details
Fachbereich: | Allgemeine Lexika |
---|---|
Genre: | Medizin |
Rubrik: | Wissenschaften |
Medium: | Buch |
Seiten: | 350 |
Inhalt: | Einband - fest (Hardcover) |
ISBN-13: | 9781032257976 |
ISBN-10: | 1032257970 |
Sprache: | Englisch |
Einband: | Gebunden |
Redaktion: |
Aranha, Hazel
Vega-Mercado, Humberto |
Hersteller: | Taylor & Francis Ltd |
Maße: | 230 x 157 x 25 mm |
Von/Mit: | Hazel Aranha (u. a.) |
Erscheinungsdatum: | 17.03.2023 |
Gewicht: | 0,636 kg |
Warnhinweis