The US Food and Drug Administration (FDA) reports that as of June 2021, 22 advanced therapy products have received regulatory approval in the United States. The first such product gained regulatory approval in 2010. Since then, hundreds of cell and gene therapies have advanced to clinical evaluation, but few products have reached commercial stages — and those that have done so have been hindered by manufacturing problems. In this eBook, writers from the BioProcess Insider and Project Farma analyze trends in cell and gene therapy investment, including a relative slow-down in investor activity compared with the surge of capital that the industry experienced during the initial phases of the COVID-19 pandemic in 2020. Then, the writers explore business- and manufacturing-related challenges that continue to hold therapy developers back from commercial success and explore potential solutions to those challenges. Among the most promising developments are holistic planning approaches to cell and gene therapy development and implementation of “flexible” manufacturing technologies and facility designs. Perhaps by incorporating such materials and strategies, the cell and gene therapy industry can usher greater numbers of candidate therapies into early manufacturing and commercial stages.

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