Reprogramming of somatic cells to generate induced pluripotent stem cells (iPSCs) has significantly advanced regenerative medicine and drug discovery. This chapter explores the diverse methods and conditions for generating iPSCs from various adult cell sources, highlighting their potential in autologous and allogeneic therapies. Key considerations for iPSC generation include the choice of reprogramming factors and systems, somatic cell sources, culture media conditions, and methods for identifying and characterizing iPSCs. High-quality materials, defined processes, and robust analytical methods are essential to ensure the safety, efficiency, and reproducibility of iPSCs. This chapter also discusses the importance of regulatory compliance, including the use of xeno-free materials and adherence to regulatory guidelines. Additionally, advances in semi-automated and automated processing are anticipated to enhance process control and reduce variability. The combination of qualified reagents, defined xeno-free workflows, and comprehensive characterization assays significantly enhances the transition of iPSC technology from research to clinical applications, paving the way for more reliable and scalable regenerative therapies and advancing the field of personalized medicine.

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Development of Standardized Methods and Analytical Tools

  • Chad C. MacArthur,
  • Uma Lakshmipathy

摘要

Reprogramming of somatic cells to generate induced pluripotent stem cells (iPSCs) has significantly advanced regenerative medicine and drug discovery. This chapter explores the diverse methods and conditions for generating iPSCs from various adult cell sources, highlighting their potential in autologous and allogeneic therapies. Key considerations for iPSC generation include the choice of reprogramming factors and systems, somatic cell sources, culture media conditions, and methods for identifying and characterizing iPSCs. High-quality materials, defined processes, and robust analytical methods are essential to ensure the safety, efficiency, and reproducibility of iPSCs. This chapter also discusses the importance of regulatory compliance, including the use of xeno-free materials and adherence to regulatory guidelines. Additionally, advances in semi-automated and automated processing are anticipated to enhance process control and reduce variability. The combination of qualified reagents, defined xeno-free workflows, and comprehensive characterization assays significantly enhances the transition of iPSC technology from research to clinical applications, paving the way for more reliable and scalable regenerative therapies and advancing the field of personalized medicine.