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Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ISPE

1 , 4 A Retrospective Journey In 2015, Vertex’s Orkambi was the first approved drug produced under a CM process for the treatment of cystic fibrosis. Chichester, UK: John Wiley & Sons, 2017. This is demonstrated by the rise from $1.05 billion US in 2021 to $1.9 Table 1: List of FDA-approved commercial products using CM elements.