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Case study: Merck Leverages Data and Analytics to Support New Continuous Drug Manufacturing Processes

Posted: 29 July 2019 | | No comments yet

Over the past couple of years, the European Medicines Agency and US Food and Drug Administration have given approvals to a handful of pharmaceutical companies to manufacture drug products using continuous manufacturing processes.

 In February 2019, the FDA released draft guidance that defined continuous manufacturing as a process in which input materials are continuously fed and transformed within the process, and the output materials are continuously removed from the system, rather than in batches.

Merck is currently using the OSIsoft PI System data infrastructure and piloting Seeq Corporation’s analytics to optimize its product and processes to support continuous manufacturing. Merck’s goal for the continuous manufacturing pilot is to minimize the traditional scale-up challenges when moving from pilot production to commercial manufacturing. Compared to traditional batch processes, continuous processing would reduce the costs associated with scale-up and transfer between equipment and site. This applies to active pharmaceutical ingredients (APIs) in particular. The project would result in flexible run times with volumes that could be adjusted to meet changing product demands. 

Click the link below to read the full report on Merck leveraging data and analytics to advance manufacturing processes.