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.
There is a revolution underway with how people are treating and eliminating their pain and discomfort. It’s called Stem Cell Therapy and what it’s able to do is nothing short of miraculous. The ability to restore perfect functions to a body party as if it were new is not a fantasy; it’s real. It doesn’t matter how scarred the tissue, how damaged the joint, or how severe the trauma, Stem Cell Therapy offers answers, and the opportunity to bring your body back to normal! This book will introduce you to Stem Cell Therapy, explain the wonders of regenerative health care, and demonstrate how it has improved the lives of people who came to us looking for solutions and found them.