3D printing brings novel doses, shapes and characteristics to 'advanced manufacturing', states Aprecia

In a blog post​ published this week, Gottlieb wrote on how the US Food and Drug Administration (FDA) needs to take steps to foster a clearer regulatory pathway to what it terms ‘advanced manufacturing’, which include 3D printing and continuous manufacturing.

Gottlieb states: “The bottom line is this: Drug makers won’t switch to these systems until we create a clear path toward their adoption, and provide more regulatory certainty that changing over to a new manufacturing system won’t be an obstacle to either new or generic drug approvals. The FDA recognises that it’ll require additional investment in policies and programmes that’ll provide regulatory clarity to enable these new methods to be more quickly and widely adopted.”

In terms of how much financial backing the new technologies had, Gottlieb identified a budget of $58m (€50m) that would be used to develop the ‘regulatory and scientific architecture’ to encourage adoption of the technology.

The future is 3D

In order to hear from the perspective of a company already working in 3D printing as a means of drug manufacture, we spoke to Tim Tracy, CEO of Aprecia Pharmaceuticals – the first company to gain FDA approval​ for a 3D-printed drug.

“From my perspective, I think he is raising some important issues, particularly around continuous manufacturing and how it’s becoming more efficient, but also around 3D printing and how it can be used to in a different fashion – with novel doses, novel shapes, sizes and characteristics of the drugs produced. I applaud his thoughts on this.”

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