Advances in Pharmaceutical Cell Therapy
Principles of Cell-Based Biopharmaceuticals
Nonfiction, Health & Well Being, Medical, Medical Science, Biotechnology, Pharmacology
| Author: | Christine Günther, Andrea Hauser, Ralf Huss | ISBN: | 9789814616805 |
| Publisher: | World Scientific Publishing Company | Publication: | September 23, 2015 |
| Imprint: | WSPC | Language: | English |
| Author: | Christine Günther, Andrea Hauser, Ralf Huss |
| ISBN: | 9789814616805 |
| Publisher: | World Scientific Publishing Company |
| Publication: | September 23, 2015 |
| Imprint: | WSPC |
| Language: | English |
This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.
The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.
This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.
Contents:
- About this Book: Why Cell Therapy?
- Regulatory Landscape and Risk-Based Approach
- Non-Clinical Development of Cell-Based Products
- Quality Management
- Process Development and Manufacturing
- Quality Control
- Cell Banking
- Product Release
- Clinical Development of Cell-Based Products
- Pharmacovigilance and Look-Back Procedures
- Personalized Cell Therapy–Biomarker & Companion Diagnostics
- Mesenchymal Stem Cells
- Next Generation Cell Therapies
- Cell-Based Gene Therapy
- Exosomes and their Therapeutic Applications
- Commercial and Business Aspects of Cell Therapy — Start-Up to Market
Readership: Students, researchers in biomedical, stem cell and molecular biology; Pharmaceutical business professionals.
Key Features:
- Unique overview of an emerging area in medicine
- Comprehensive textbook
- New edition
This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.
The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.
This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.
Contents:
- About this Book: Why Cell Therapy?
- Regulatory Landscape and Risk-Based Approach
- Non-Clinical Development of Cell-Based Products
- Quality Management
- Process Development and Manufacturing
- Quality Control
- Cell Banking
- Product Release
- Clinical Development of Cell-Based Products
- Pharmacovigilance and Look-Back Procedures
- Personalized Cell Therapy–Biomarker & Companion Diagnostics
- Mesenchymal Stem Cells
- Next Generation Cell Therapies
- Cell-Based Gene Therapy
- Exosomes and their Therapeutic Applications
- Commercial and Business Aspects of Cell Therapy — Start-Up to Market
Readership: Students, researchers in biomedical, stem cell and molecular biology; Pharmaceutical business professionals.
Key Features:
- Unique overview of an emerging area in medicine
- Comprehensive textbook
- New edition
