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Handbook of Cell and Gene Therapy
From Proof-of-Concept through Manufacturing to Commercialization
Buch von Hazel Aranha (u. a.)
Sprache: Englisch

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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
preigu-id: 126429182
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
preigu-id: 126429182
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