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Manufacturing is a critical aspect of complex biologic products. The adage that “the process is the product” is all too true. This has only been highlighted by the COVID-19 pandemic during which limitations in manufacturing were encountered and have had to be overcome. Advancing manufacturing technology is critical for the production of complex biologic products on a small, medium, and large scale. Right now there a Goldilocks phenomenon present: manufacturing appears to be best suited to the medium scale. However it will be important that we can both scale down and scale up in order to meet important medical needs. FDA is conducting and sponsoring applied scientific research and refining the regulatory framework for advanced manufacturing. The agency will also be working with academic, industrial, and federal partners to help advance the field.
