Flexible Manufacturing: The Future State of Drug Product Development and Commercialization in the Pharmaceutical Industry
Flexible manufacturing systems are needed in the pharmaceutical industry due to the future challenges of volatility, uncertainty, complexity, and ambiguity . Compared to traditional manufacturing systems that dominate the pharmaceutical industry today, processes that are better able to react to changes in the types of products being sold, the volume of sales, and the facilities needed for production will be an asset to an organization. Many emerging technologies are inherently adaptable, though the types of flexibility exhibited vary widely. The nature of these emerging technologies is examined here, and the case is made that flexibility should be valued as much as cost and time when selecting technologies, even though flexible manufacturing systems require extra time and money initially. An outlook on this type of manufacturing is shared with the assertion that flexible development and manufacturing would help reduce overall cost and better serve patient needs following the initial investment period. In the next decade, concentrated effort is needed from industry, academia, suppliers, and regulators to enable more agile and nimble pharmaceutical development and manufacturing.
KeywordsFlexibility PODS Robotics 3D printing Digital Continuous manufacturing
We would like to thank Richard Osifchin, Jennifer Baxter, Ian McConnell, Cathy McFerran, and Heidi Ferguson in Preclinical Development and Joseph Kukura in Global Pharmaceutical Operations at Merck & Co., Inc., Kenilworth, NJ, USA, for their insightful comments and guidance.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
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