This book examines the technologies and processes for the development and commercial production of stem cells according to c GMP 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.
Inhoudsopgave
Chapter 1. Stem Cell Therapy: Significance and Applications of Stem Cell Products in the Tissue Engineering and Regenerative Medicine.- Chapter 2. GLP Requirements of Stem Cells.- Chapter 3. Current Good Manufacturing Practice (CGMP) Facility and Production of Stem Cell.- Chapter 4. Global Regulatory Frameworks and Quality Standards for Stem Cells Therapy and Regenerative Medicines.- Chapter 5. Stem Cell Bioreactors: Design, Structure and Operation of Stem Cell Bioreactors.- Chapter 6. Stem Cell Culture and Expansion: Role of culture, Types of Cells, Growth Conditions, Media Nutrients, Growth Factors, Growth Phase Cycle.- Chapter 7. UP Scaling of Clinical Grade Stem Cell Production-Upstream Processing (USP) and Downstream Processing (DSP) Operations of Cell Expansion, Harvesting, Detachment, Separation, Washing and Concentration Steps, and the Regulatory Requirements.- Chapter 8. Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and their Products According to Regulatory Requirements for FDA Approval.- Chapter 9. Stem Cell Safety and Sterility Testing: A Promising Approach in Regenerative Medicine.- Chapter 10. Stem Cells Storage, Packaging and Transportation.- Chapter 11. Stem Cell Clinical Trials and Stem Cell Market.-
Over de auteur
Firdos Alam Khan is a Professor and Chairman at the Department of Stem Cell Biology, Institute for Research and Medical Consultations (IRMC), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. He has obtained his Ph.D. in Zoology with a specialization in Neuroscience from Nagpur University, India. Over the past 24 years, Professor Khan is involved in teaching various courses such as Cell Biology, Pharmacology, Business of Biotechnology, Biomedicine, Cell & Tissue Engineering, and Bioethics & IPR to undergraduate and postgraduate students. He was previously associated with the Manipal Academy of Higher Education, Dubai Campus, United Arab Emirates. He was a Professor and Chairperson, School of Life Sciences and served as Chairman of Research & Development Program. He has published more than 75 research articles in several peer-reviewed journals.
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