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.

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

  • Pelin Kılıç,
  • Cansu Özdemir,
  • Begüm Coşar,
  • Büşra Nigar Savran,
  • Aysun Sarıkaya,
  • Begüm Sargon,
  • Alım Toprakkale,
  • İrem Songür,
  • Özlem Kandemir Seçgin,
  • Pınar Akpınar Oktar,
  • Elif NazIı Çetindağ,
  • Deniz Yurtsever Sarıca,
  • Serpil Taşdelen,
  • Üstün Ezer,
  • Ahmet Emin Kürekçi,
  • Günhan Gürman

摘要

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.