ADVANCES IN PHARMACEUTICAL CELL THERAPY: PRINCIPLES OF CELL-BASED BIOPHARMACEUTICALS

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.

This textbook is a comprehensive overview of the emerging field of cell-based biopharmaceuticals starting from the underlying biology of stem cell and cell-based products all the way to the initiation of a pivotal clinical trial and the potential business model behind it.

It also takes into consideration the different regulatory landscapes in Europe, North America and other parts of the world and describes a way to manufacture a pharmaceutical-grade therapeutic that passes all necessary quality measures as a robust and marketable product. This is an important guide for any professional in the field of cell-based biopharmaceuticals, needing insights from scientific, medical and business perspectives in one convenient volume.