While making the switch from batch to continuous manufacturing may not be new in many other industries, it is revolutionizing pharmaceutical and biotech manufacturing. Laura Wareham, Senior Scientist, Engineering, at Merck's manufacturing division, states that while continuous manufacturing may be well-established in other high-volume industries, it is still relatively new to the pharmaceutical space. The pharmaceutical industry is a highly regulated, science-based, and largely batch-oriented industry with a large base of batch manufacturing equipment already installed, making the switch to continuous manufacturing a large undertaking.
Despite the upfront capital expense required to replace legacy equipment and overcome perceived regulatory hurdles, continuous manufacturing can lead to innovative products and processes while helping pharma companies scale up and deliver high-quality products with flexible batch sizes to meet changing market demands.
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 In February 2019, the FDA released a draft guidance that defined continuous manufacturing as a process in which input materials are continuously fed and transformed within the process and the output materials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 for 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.
Read the full report on Merck leveraging data and analytics to advance manufacturing processes here.
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