Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations

ISBN-13: 9781071613290 / Angielski / Miękka / 2022 / 302 str.

Turksen, Kursad

Opis

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 improvements to GMP and accelerate new stem cell treatments for patients in need.

Spis treści

1. 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, and Lee Ann Applegate

 

2. 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, and Lee Ann Applegate

 

3. 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, Anthony S. de Buys Roessingh, and Lee Ann Applegate

 

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

            Olga Nehir Öztel, Nurullah Aydoğdu, and Erdal Karaöz

 

5. The Isolation, Culturing, Cryopreservation, and the Preparation as a Final Cellular Product of the Umbilical Cord-Derived Mesenchymal Stem Cells Under Good Manufacturing Practices Conditions

            Nurullah Aydoğdu, Olga Nehir Öztel, and Erdal Karaöz

 

6. The Isolation, Culture, Cryopreservation, and the Preparation as a Final Cellular Product of the Skin-Derived Fibroblasts Under Good Manufacturing Practice Conditions

            Nurullah Aydoğdu, Olga Nehir Öztel, and Erdal Karaöz

 

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

            Rhayra B. Dias and Danielle C. Bonfim

 

8. 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, and Cláudia Lobato da Silva

 

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

            Giuseppe Maria de Peppo

 

10. 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, Lucia Turchetto, and Marina Radrizzani

 

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

            Diogo E.S. Nogueira, Carlos A.V. Rodrigues, Yas Hashimura, Sunghoon Jung, Brian Lee, and Joaquim M.S. Cabral

 

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

            Mehdi Dashtban, Krishna Morgan Panchalingam, Mehdi Shafa, and Behnam Ahmadian Baghbaderani

 

13. 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, Bagher Larijani, and Babak Arjmand

 

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

            Hamid Reza Aghayan, Moloud Payab, Fereshteh Mohamadi-Jahani, Seyed Sajjad Aghayan, Bagher Larijani, and Babak Arjmand

 

15. GMP-Compliant Human Schwann Cells Manufacturing for Clinical Application

            Babak Arjmand, Parisa Goodarzi, Sepideh Alavi-Moghadam, Moloud Payab, Hamid Reza Aghayan, Fereshteh Mohamadi-Jahani, Akram Tayanloo-Beik, Neda Mehrdad, and Bagher Larijani

 

16. GMP-Compliant Adenoviral Vectors for Gene Therapy

            Babak Arjmand, Sepideh Alavi-Moghadam, Moloud Payab, Parisa Goodarzi, Motahareh Sheikh Hosseini, Akram Tayanloo-Beik, Mostafa Rezaei-Tavirani, and Bagher Larijani

 

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

            Joaquim Vives, Luciano Rodríguez, Maria Isabel Coca, Laura Reales, Raquel Cabrera-Pérez, and Lluís Martorell

 

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

            Pelin Kilic