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Chimeric Antigen Receptor-T Cell (CAR)-T cell therapy is poised to transform cancer therapy for hematologic malignancies and is expanding into solid tumors. This chapter outlines status quo of CAR-T therapy and offers an overview of both advancements and challenges. We note significant improvements in CAR-T therapy processes and logistics as innovation technologies moved from academia into commercialized functional clinical applications. These logistical challenges present variability in patient-specific shocks and face Good Manufacturing Practice (GMP) implications. Innovation in commercialized processing technologies helps with efficiency, scalability, and costs, with greater emphasis on point-of-care manufacturing that reduces processing time and improves accessibility for patients critically requiring action. The complexities of the creation of decentralized models are noted and discussed alongside operational considerations of regulatory implications. To address the significant anticipated demand for therapies targeting cancer cells, we discuss automated, closed systems developed to enhance scalability while reducing variability and maintaining product integrity. We will briefly summarize CAR-T cell efficacy findings from trials for treatment of hematologic cancers and emerging data targeting solid tumors, including trial findings and ongoing case analysis. This chapter also includes a section addressing quality control, ultimately underscoring the importance of quality as it relates to consistency of the therapeutic within the production process. This chapter explores clinical manufacturing practices, recent technological innovations in CAR-T cell development, and strategies for product distribution, along with key clinical and regulatory considerations. It also presents a focused discussion on quality control and assurance, emphasizing the importance of maintaining therapeutic integrity throughout the production process. The discussion concludes by highlighting prospective advancements in CAR-T therapy, including the development of next-generation platforms, expansion into diverse therapeutic areas, and analysis of emerging trends—all of which signal a transformative future for cancer treatment. These insights, supported by a comprehensive list of references, offer a solid foundation for ongoing research and clinical innovation in the field.

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From Bench to Bedside: Innovations and Challenges in CAR-T Cell Therapy Manufacturing and Regulation

  • 章节

  • 发表日期：

    2026年

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  • Joyeeta Talukdar,
  • Debabrat Baishya,
  • Subhradip Karmakar,
  • Arabinda Ghosh,
  • Tulika Seth,
  • Umesh Kumar,
  • Anushuya Ghatak

摘要

Chimeric Antigen Receptor-T Cell (CAR)-T cell therapy is poised to transform cancer therapy for hematologic malignancies and is expanding into solid tumors. This chapter outlines status quo of CAR-T therapy and offers an overview of both advancements and challenges. We note significant improvements in CAR-T therapy processes and logistics as innovation technologies moved from academia into commercialized functional clinical applications. These logistical challenges present variability in patient-specific shocks and face Good Manufacturing Practice (GMP) implications. Innovation in commercialized processing technologies helps with efficiency, scalability, and costs, with greater emphasis on point-of-care manufacturing that reduces processing time and improves accessibility for patients critically requiring action. The complexities of the creation of decentralized models are noted and discussed alongside operational considerations of regulatory implications. To address the significant anticipated demand for therapies targeting cancer cells, we discuss automated, closed systems developed to enhance scalability while reducing variability and maintaining product integrity. We will briefly summarize CAR-T cell efficacy findings from trials for treatment of hematologic cancers and emerging data targeting solid tumors, including trial findings and ongoing case analysis. This chapter also includes a section addressing quality control, ultimately underscoring the importance of quality as it relates to consistency of the therapeutic within the production process. This chapter explores clinical manufacturing practices, recent technological innovations in CAR-T cell development, and strategies for product distribution, along with key clinical and regulatory considerations. It also presents a focused discussion on quality control and assurance, emphasizing the importance of maintaining therapeutic integrity throughout the production process. The discussion concludes by highlighting prospective advancements in CAR-T therapy, including the development of next-generation platforms, expansion into diverse therapeutic areas, and analysis of emerging trends—all of which signal a transformative future for cancer treatment. These insights, supported by a comprehensive list of references, offer a solid foundation for ongoing research and clinical innovation in the field.