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As cell-based therapies near widespread clinical use, robust data management systems are crucial for ensuring safety, efficacy, and regulatory compliance. This chapter reviews the ISO 8472 series, which focuses on data interoperability for stem cell applications, and highlights the complexities of managing clinical, manufacturing, and quality control data. It underscores the need for standardized frameworks to streamline data sharing, analysis, and validation. Additionally, emerging technologies like AI and blockchain are explored for their potential to revolutionize data management, enhance security, and improve automation. Furthermore, this chapter addresses challenges in implementing data standards in cell therapy manufacturing and ensuring transparency. It outlines strategies to foster collaboration among stakeholders, including regulatory bodies, biobanks, CROs, and manufacturers, to drive innovation and scalability. Establishing comprehensive standards and interoperable data systems is essential for building trust and facilitating the commercialization of stem cell therapies.

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Development of Stem Cell Data Systems and Associated Data Standards for Cell Therapy

  • 章节

  • 发表日期：

    2025年

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  • Yong Zhang,
  • Andreas Kurtz,
  • Hongling Zhao,
  • Lei Wang,
  • Jie Hao,
  • Martin Golebiewski,
  • Glyn N. Stacey,
  • Tongbiao Zhao

摘要

As cell-based therapies near widespread clinical use, robust data management systems are crucial for ensuring safety, efficacy, and regulatory compliance. This chapter reviews the ISO 8472 series, which focuses on data interoperability for stem cell applications, and highlights the complexities of managing clinical, manufacturing, and quality control data. It underscores the need for standardized frameworks to streamline data sharing, analysis, and validation. Additionally, emerging technologies like AI and blockchain are explored for their potential to revolutionize data management, enhance security, and improve automation. Furthermore, this chapter addresses challenges in implementing data standards in cell therapy manufacturing and ensuring transparency. It outlines strategies to foster collaboration among stakeholders, including regulatory bodies, biobanks, CROs, and manufacturers, to drive innovation and scalability. Establishing comprehensive standards and interoperable data systems is essential for building trust and facilitating the commercialization of stem cell therapies.