Handbook of Cell and Gene Therapy
portes grátis
Handbook of Cell and Gene Therapy
From Proof-of-Concept through Manufacturing to Commercialization
Aranha, Hazel; Vega-Mercado, Humberto
Taylor & Francis Ltd
03/2023
350
Dura
Inglês
9781032257976
15 a 20 dias
Descrição não disponível.
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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Gene therapy;Clinical to commercial manufacturing;Viral vectors and plasmid manufacturing;Vector design and construction;Risk-based approach in the development of cell and gene therapy products;Regulatory landscape for gene and cell therapies;Gene Therapy Products;PMDA;Advanced Therapy Product;Marketing Authorisation Applications;GTMP;Advanced Therapy;CRISPR;ATMP;Ich Q7;Allogenic Therapies;Genome Editing;Overwhelming Immune Reaction;Pharmaceutical Inspection Co-operation Scheme;Chimeric Antigen Receptors;Orphan Drug Designation;ZFN.;Breakthrough Therapy Designation;Regenerative Medicine;Somatic Cell Therapy;Marketing Authorization Application;Biological Medicinal Product;QC Testing;Ich Q2;Marketing Authorization
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Gene therapy;Clinical to commercial manufacturing;Viral vectors and plasmid manufacturing;Vector design and construction;Risk-based approach in the development of cell and gene therapy products;Regulatory landscape for gene and cell therapies;Gene Therapy Products;PMDA;Advanced Therapy Product;Marketing Authorisation Applications;GTMP;Advanced Therapy;CRISPR;ATMP;Ich Q7;Allogenic Therapies;Genome Editing;Overwhelming Immune Reaction;Pharmaceutical Inspection Co-operation Scheme;Chimeric Antigen Receptors;Orphan Drug Designation;ZFN.;Breakthrough Therapy Designation;Regenerative Medicine;Somatic Cell Therapy;Marketing Authorization Application;Biological Medicinal Product;QC Testing;Ich Q2;Marketing Authorization
