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Stem Cells and Good Manufacturing Practices

Methods, Protocols, and Regulations

  • Book
  • © 2021

Overview

Editors:
  1. Kursad Turksen

    1. Ottawa, Canada

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  • Includes cutting-edge techniques
  • Provides step-by-step detail essential for reproducible results
  • Contains key implementation advice from the experts

Part of the book series: Methods in Molecular Biology (MIMB, volume 2286)

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Table of contents (18 protocols)

  1. Front Matter

    Pages i-xii
    Download chapter PDF

  2. Swiss Fetal Transplantation Program and Non-enzymatically Isolated Primary Progenitor Cell Types for Regenerative Medicine

    • Alexis Laurent, Corinne Scaletta, Nathalie Hirt-Burri, Wassim Raffoul, Anthony S. de Buys Roessingh, Lee Ann Applegate
    Pages 1-24

  3. GMP Tiered Cell Banking of Non-enzymatically Isolated Dermal Progenitor Fibroblasts for Allogenic Regenerative Medicine

    • Alexis Laurent, Corinne Scaletta, Murielle Michetti, Nathalie Hirt-Burri, Anthony S. de Buys Roessingh, Wassim Raffoul et al.
    Pages 25-48

  4. Progenitor Biological Bandages: An Authentic Swiss Tool for Safe Therapeutic Management of Burns, Ulcers, and Donor Site Grafts

    • Alexis Laurent, Corinne Scaletta, Murielle Michetti, Nathalie Hirt-Burri, Marjorie Flahaut, Wassim Raffoul et al.
    Pages 49-65

  5. Validation of the Media Fill Method for Solid Tissue Processing in Good Manufacturing Practice–Compliant Cell Production

    • Olga Nehir Öztel, Nurullah Aydoğdu, Erdal Karaöz
    Pages 67-71

  6. Isolation, Culture, Cryopreservation, and Preparation of Umbilical Cord-Derived Mesenchymal Stem Cells as a Final Cellular Product Under Good Manufacturing Practices–Compliant Conditions

    • Nurullah Aydoğdu, Olga Nehir Öztel, Erdal Karaöz
    Pages 73-84

  7. Isolation, Culture, Cryopreservation, and Preparation of Skin-Derived Fibroblasts as a Final Cellular Product Under Good Manufacturing Practice–Compliant Conditions

    • Nurullah Aydoğdu, Olga Nehir Öztel, Erdal Karaöz
    Pages 85-94

  8. The Isolation and Manufacture of GMP-Grade Bone Marrow Stromal Cells from Bone Specimens

    • Rhayra B. Dias, Danielle C. Bonfim
    Pages 95-105

  9. Scalable Manufacturing of Human Hematopoietic Stem/Progenitor Cells Exploiting a Co-culture Platform with Mesenchymal Stromal Cells

    • Ana Fernandes-Platzgummer, Pedro Z. Andrade, Joaquim M. S. Cabral, Cláudia Lobato da Silva
    Pages 107-120

  10. GMP-Compatible, Xeno-Free Culture of Human Induced Mesenchymal Stem Cells

    • Giuseppe Maria de Peppo
    Pages 121-129

  11. GMP-Grade Methods for Cardiac Progenitor Cells: Cell Bank Production and Quality Control

    • Gabriella Andriolo, Elena Provasi, Andrea Brambilla, Viviana Lo Cicero, Sabrina Soncin, Lucio Barile et al.
    Pages 131-166

  12. Suspension Culture of Human Induced Pluripotent Stem Cells in Single-Use Vertical-Wheel™ Bioreactors Using Aggregate and Microcarrier Culture Systems

    • Diogo E. S. Nogueira, Carlos A. V. Rodrigues, Yas Hashimura, Sunghoon Jung, Brian Lee, Joaquim M. S. Cabral
    Pages 167-178

  13. Addressing Manufacturing Challenges for Commercialization of iPSC-Based Therapies

    • Mehdi Dashtban, Krishna Morgan Panchalingam, Mehdi Shafa, Behnam Ahmadian Baghbaderani
    Pages 179-198

  14. Standard Operating Procedure for the Good Manufacturing Practice-Compliant Production of Human Endometrial Stem Cells for Multiple Sclerosis

    • Somayeh Ebrahimi-Barough, Jafar Ai, Moloud Payab, Sepideh Alavi-Moghadam, Ameneh Shokati, Hamid Reza Aghayan et al.
    Pages 199-212

  15. GMP-Compliant Production of Human Placenta-Derived Mesenchymal Stem Cells

    • Hamid Reza Aghayan, Moloud Payab, Fereshteh Mohamadi-Jahani, Seyed Sajjad Aghayan, Bagher Larijani, Babak Arjmand
    Pages 213-225

  16. GMP-Compliant Human Schwann Cell Manufacturing for Clinical Application

    • Babak Arjmand, Parisa Goodarzi, Sepideh Alavi-Moghadam, Moloud Payab, Hamid Reza Aghayan, Fereshteh Mohamadi-jahani et al.
    Pages 227-235

  17. GMP-Compliant Adenoviral Vectors for Gene Therapy

    • Babak Arjmand, Sepideh Alavi-Moghadam, Moloud Payab, Parisa Goodarzi, Motahareh Sheikh Hosseini, Akram Tayanloo-Beik et al.
    Pages 237-250

  18. Use of Multipotent Mesenchymal Stromal Cells, Fibrin, and Scaffolds in the Production of Clinical Grade Bone Tissue Engineering Products

    • Joaquim Vives, Luciano Rodríguez, Maria Isabel Coca, Laura Reales, Raquel Cabrera-Pérez, Lluís Martorell
    Pages 251-261

  19. Quality Management Systems (QMSs) of Human-Based Tissue and Cell Product Manufacturing Facilities

    • Pelin Kilic
    Pages 263-279

  20. Back Matter

    Pages 281-288
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Keywords

About this book

This detailed book explores the utilization and delivery of stem cells for therapeutic purposes in patients in the clinic and the tightly controlled Good Manufacturing Practices (GMP) that make these powerful techniques possible. Fully updated and expanded from the first edition, this collection features a new set of protocols to arm stem cell biologists with protocols that are currently being used in a number of well-established facilities around the world. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. 

Authoritative and up to date, Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations, Second Edition serves as an ideal guide for researchers aiming to drive continued improvementsto GMP and accelerate new stem cell treatments for patients in need.

Editors and Affiliations

  • Ottawa, Canada

    Kursad Turksen

Bibliographic Information

  • Book Title: Stem Cells and Good Manufacturing Practices

  • Book Subtitle: Methods, Protocols, and Regulations

  • Editors: Kursad Turksen

  • Series Title: Methods in Molecular Biology

  • DOI: https://doi.org/10.1007/978-1-0716-1327-6

  • Publisher: Humana New York, NY

  • eBook Packages: Springer Protocols

  • Copyright Information: Springer Science+Business Media, LLC, part of Springer Nature 2021

  • Hardcover ISBN: 978-1-0716-1326-9Published: 01 April 2021

  • Softcover ISBN: 978-1-0716-1329-0Published: 02 April 2022

  • eBook ISBN: 978-1-0716-1327-6Published: 31 March 2021

  • Series ISSN: 1064-3745

  • Series E-ISSN: 1940-6029

  • Edition Number: 2

  • Number of Pages: XII, 288

  • Number of Illustrations: 10 illustrations in colour

  • Topics: Stem Cells, Industrial Chemistry/Chemical Engineering

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