000 03857nam a22004455i 4500
001 978-981-16-7589-8
003 DE-He213
005 20240729133944.0
007 cr nn 008mamaa
008 220329s2022 si | s |||| 0|eng d
020 _a9789811675898
_9978-981-16-7589-8
024 7 _a10.1007/978-981-16-7589-8
_2doi
072 7 _aPSC
_2bicssc
072 7 _aSCI072000
_2bisacsh
072 7 _aPSC
_2thema
245 1 0 _aStem Cell Production
_b : Processes, Practices and Regulations /
250 _a1st ed. 2022.
264 1 _aSingapore :
_bSpringer Nature Singapore :
_bImprint: Springer,
_c2022.
300 _aXI, 272 p. 1 illus.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aChapter 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-GradeStem 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.-.
520 _aThis 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.
650 0 _aStem cells.
650 0 _aRegenerative medicine.
650 0 _aTherapeutics.
650 1 4 _aStem Cell Biology.
650 2 4 _aRegenerative Medicine and Tissue Engineering.
650 2 4 _aTherapeutics.
700 1 _aKhan, Firdos Alam.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
710 2 _aSpringerLink (Online service)
856 _u#gotoholdings
_yAccess resource
912 _aZDB-2-SBL
912 _aZDB-2-SXB
245 _h[E-Book]
999 _c100962
_d100962