MSCs as Biological Drugs: From Manufacturing to Commercialization-Reference-Cited by-同舟云学术

MSCs as Biological Drugs: From Manufacturing to Commercialization

Published:2024-02-21 Issue: Volume: Page:160-173
ISSN:
Container-title:Stem Cells in Clinical Application and Productization
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Author:

Yu Hao¹,Yang Xiaonan²,Zhao Meng³,Zhang Leisheng⁴

Affiliation:

1. The Postdoctoral Research Station, School of Medicine, Nankai University, Tianjin, 300071, China

2. Department of Plastic and Reconstructive Surgery, Plastic Surgery Hospital Affiliated to Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100144, China

3. National Engineering Research Center of Cell Products, AmCellGene Engineering Co., Ltd, Tianjin, 300457, China

4. Jiangxi Research Center of Stem Cell Engineering, Jiangxi Health-Biotech Stem Cell Technology Co., Ltd., Shangrao, 334000, China

Abstract

Mesenchymal stem/stromal cells (MSCs) can be used as a therapeutic agent in regenerative medicine, owing to their unique self-renewal, multi-lineage differentiation, and immunoregulation properties. The manufacturing of authorized MSC products should depend on good manufacturing practices (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). Until now, many biotech companies have invested in developing the clinical application of MSC product all over the world. Meanwhile, the application of MSC products for human use must comply with regulations and guidance for a biotech company. In this chapter, we discuss the process and development of MSC products from production-manufacturing to commercialization.<br>

Publisher

BENTHAM SCIENCE PUBLISHERS

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