Emerging Ethical Challenges in Manufacturing of Cell-Based Medicines

This chapter explores new ethical issues raised by recent developments in the manufacture of cell-based medicines and revisit ethical issues that havepreviously been acknowledged in the context of contemporary technologies. We follow the translational pathway of cell-based medicines and address ethical challenges along the way. Our journey encompasses a thorough examination of five central themes: (1) the complexities in the informed consent process, (2) the intricacies of cell banking and distributing, (3) the crucial role of governance and oversight, (4) the significance of representation, diversity, and equity in translational research and (5) the responsibility to enable access to effective cell-based products. This discussion also underlines the responsibility of the scientific community to be aware of, and where possible, address these challenges. By describing the ethical questions parallel to the translational process, this chapter provides a streamlined overview of the ethical challenges of cell therapy manufacturing.