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. 2025:2939:265-279.
doi: 10.1007/7651_2024_553.

Upstream Process Protocol for MSCs Isolated from Different Human-Based Tissue Origins

Affiliations

Upstream Process Protocol for MSCs Isolated from Different Human-Based Tissue Origins

Pelin Kılıç et al. Methods Mol Biol. 2025.

Abstract

This chapter introduces the increasing significance of mesenchymal stromal/stem cell (MSC) production in regenerative medicine and cellular therapeutics, outlines the growing interest in MSCs for various medical applications, and highlights their potential in advanced therapy medicinal products (ATMPs) and the advancements in cell culture technologies that have facilitated large-scale MSC production under Good Manufacturing Practices (GMP), ensuring safety and efficacy. This chapter describes an optimized upstream protocol for laboratory-scale MSC production from different tissue sources. This protocol, conducted in flasks, controls critical parameters and lays the foundation for downstream processing to generate ATMPs. This comprehensive approach underscores the potential of MSCs in clinical applications and the importance of tailored production processes.

Keywords: Advanced therapy medicinal products (ATMPs); Bone marrow-derived mesenchymal stromal/stem cells (BM-MSCs); Cell culture; Cryopreservation; Good Manufacturing Practices (GMP); Isolation; Master cell bank (MCB); Passaging; Perinatal tissue-derived mesenchymal stromal/stem cells (PNT-MSCs); Working cell bank (WCB).

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