Stem Cell Production : Processes, Practices and Regulations

This book examines the technologies and processes for the development and commercial production of stem cells according to cGMP guidelines. Further, it summarizes characterization strategies of clinical grade stem cells for stem cell therapy.

This book examines the technologies and processes for the development and commercial production of stem cells according to cGMP guidelines. The initial chapter of the book discusses the therapeutic potentials of stem cells for the treatment of various diseases, including degenerative disorders and genetic diseases. The book then reviews the recent developments in the cultivation of stem cells in bioreactors, including critical cultural parameters, possible bioreactor configuration and integrations of novel technologies in bioprocess developmental stages. The book also introduces microscopic, molecular, and cellular techniques for characterization of stem cells for regulatory approvals. Further, it describes optimal cell transporting conditions to maintain cell viability and properties. Further, it summarizes characterization strategies of clinical grade stem cells for stem cell therapy. This book is an invaluable contribution to having an academic and industrial understanding with respect to R&D and manufacturing of clinical grade stem cells.