Continuous chemical manufacturing technology has been in use for more than 100 years producing high-volume commodity chemicals. However, it was not until the early 2000s that the technology caught the attention of the pharmaceutical industry in a significant way.
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A noteworthy milestone was in 2007, when a grant from Novartis to MIT led to the creation of the Novartis-MIT Center for Continuous Manufacturing, an ambitious multi-investigator programme to integrate continuous drug substance and drug product manufacturing.1 There are several reasons why the adoption of continuous manufacturing (CM) for drugs lagged applications elsewhere. The broad diversity of chemistries used to manufacture drugs and the multitude of unit operations make the general application of CM complex. Additionally, the relatively small annual production volumes of individual drug substances do not benefit from the economies of scale provided by CM, when compared to large volume commodity chemicals. For pharmaceuticals, the motivating factors likely include the desire for greater quality control, along with expected improvements in safety and efficiency. The Novartis-MIT project culminated in a 2013 publication describing an end-to-end continuous process to produce aliskiren drug substance, and formulated drug product, at pilot scale.2
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