Stem cell production: processes, practices and regulations / Firdos Alam Khan, editor.
Khan, Firdos Alam, editor.
2022
QH588.S83
Available Online

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Title
Stem cell production: processes, practices and regulations / Firdos Alam Khan, editor.
ISBN
9789811675898 (electronic bk.)
9811675899 (electronic bk.)
9811675880
9789811675881
DOI
https://doi.org/10.1007/978-981-16-7589-8
Publication Details
Singapore : Springer, 2022.
Language
English
Description
1 online resource
Item Number
10.1007/978-981-16-7589-8 doi
Call Number
QH588.S83
Dewey Decimal Classification
616.02/774
Summary
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.
Access Note
Access limited to authorized users.
Source of Description
Online resource; title from PDF title page (SpringerLink, viewed April 12, 2022).
Added Author
Khan, Firdos Alam, editor.
Available in Other Form
Print version: 9789811675881
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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.-.

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