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.
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