CELL AND GENE THERAPIES

Over the past year, BPI readers continued to be highly interested in the development, manufacture, and characterization of cell and gene therapies (CGTs). As evidenced by this year's nominees, scalability and quality concerns remain at the front of scientists' minds. Featured in this eBook are BPI's top four articles about cell and gene therapy production from September 2020 through June 2021.

Apte et al. explore factors that continue to complicate CGT manufacturing, then highlight regulatory pathways that could help therapy developers to fast-track their products to the market. Bream and Salzmann present findings from a survey of 150 biopharmaceutical industry leaders concerning CGT facility requirements and preparations for increasing production capabilities. Goldberg overviews analytical performance characteristics that must be considered during development and validation of assays for cell therapy products. And Jin describes how Droplet Digital polymerase chain reaction (ddPCR) assays can be used to track and quantify chimeric antigen receptor (CAR) gene sequences in transduced T cells.

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