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Manufacture Small Molecules

Continuous Progress

Implementation of continuous manufacturing (CM) is long overdue in pharma. High margins and intense regulatory scrutiny has left us lagging behind other industries. But as the market gets tougher and regulators make it clear they want to see more sophisticated manufacturing, the roadblocks are crumbling. Change is coming, like it or not.

The advantages are well documented, both in terms of improved quality and lower costs. Because you’re working with a much smaller amount of material at any one point, scrutiny and control of the process is enhanced. On the cost side, the biggest savings come from improved efficiency, reduced batch rejection, faster production and fewer staff.

There are also huge savings to be made in development. For example, here at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), we worked with one company to develop a continuous process for an existing product. To carry out design of experiments (DOE) for the process using a batch model required around 4000 kg of active pharmaceutical ingredient (API);  a continuous process cut that down to 150 kg. Given that the API in question carries a price tag of up to $10,000 per kg, it was a huge saving.  Savings of this level more than cover the capital expense of a new facility and manufacturing line.

Another area where CM comes into its own is in combination products. We recently worked on a project involving a combination product with six different dosage ratios, with impressive results. In a CM line you can switch between dosage ratios in real time – there’s no need to shut down and re-calibrate – it’s as simple as entering a command into your control system.

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About the Author

Doug Hausner

Doug Hausner is Associate Director for Industrial Relations and Business Development at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Rutgers University, NY, USA.

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