Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
ISPE
JULY 6, 2023
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. 17 (2011):10083–92. addresses the risk-based decision-making process as a consequence of the previously defined level of formality, alongside the levels of effort and documentation.
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