In this episode, Anne, Carol, and Steve Keizer discuss the differences between cell and gene therapy and traditional drug manufacturing. They explore the challenges and unique aspects of cell and gene therapy manufacturing, including the need for aseptic manufacturing, patient-specific treatments, and single-unit manufacturing. They also discuss the differences in regulations and audits for cell and gene therapy products. The conversation covers topics such as stability studies, retained samples, and the challenges of distribution and transportation. The episode concludes with a discussion on the market size and impact of cell and gene therapy, as well as the skills and education required for individuals interested in this field.

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