De-risking cell therapy product development: strategies for commercial success

As the field of cell and gene-modified cell therapies continues to rapidly advance, manufacturing processes and analytics must be de-risked in development before entering the clinic to mitigate technology transfer and clinical development setbacks. Thus, a scalable and robust framework for new products is critical to repeatably and reliably guide cross-functional teams through the product lifecycle. In this article, experts from Charles River Laboratories discuss FLEX Platforms in addition to the new product introduction framework and how this approach is applied to streamline the complex journey to the clinic and beyond. Central to the project inception of new products is the implementation of effective commercial readiness risk management strategies from the early stages of development. By identifying potential risks early and proactively addressing them, a more efficient progression through the entire process can be ensured.

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