Full Description
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
Why Cell Therapy; Risk Based Approach; Preclinical Development; Clinical Development; Process Development and Manufacturing; Materials; Banking; Quality Control and Pharmaceutical Development; Quality Management; Product Release; Pharmacovigilance; Cell-Based Therapy Trials; Personalised Cell Therapy And Biomarkers; Commercialisation of Cell Products; Next-Generation Cell Therapies; Extracellular Vesicles for Therapy;
