FDA Wants to use AI to Assess Pharmaceuticals

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The agency is looking for a small business to provide the service to help examine freeze-dried pharmaceuticals and complex generic drug products.

The Food and Drug Administration is looking to use artificial intelligence to help characterize pharmaceutical products , according to a small business sources sought notice filed on Wednesday. 

The FDA’s Division of Product Quality performs research “to advance the adoption of emerging technology for pharmaceutical manufacturing” and for the development of generic drugs, the notice stated. As a result, the division is looking for a contractor to provide high-resolution images and perform an analysis of the images with artificial intelligence to characterize “freeze-dried pharmaceuticals and complex drug products.” 

The AI analysis will help the FDA understand the role of advanced manufacturing techniques, formulas and process parameters on the quality of products and their performance. This will be accomplished by measuring and simulating physical and microstructural parameters, then connecting those with product performance and process. 

Although freeze drying—a commonly used process in drug manufacturing—is not necessarily an advanced manufacturing technology by itself, it may utilize some advanced manufacturing technologies.

“Physical and microstructural parameters are attributes of a freeze dried drug product,” an FDA spokesperson told Nextgov. “The ability to readily measure these attributes could enable an understanding of how these attributes are impacted by changes to a manufacturing process and how changes in these attributes might impact drug product performance. Similarly for complex products, microstructural parameters can impact drug release. The microstructure of a complex product can be influenced by the formulation and the manufacturing process.”

Artificial intelligence could then give the FDA another method of examining such characteristics.

“One potential application of high resolution imaging combined with AI image analysis methods is to determine the equivalence of generic drug products to innovator drug products, including complex generic products and products made using advanced manufacturing techniques, though there are many others,” the spokesperson said.

The performance period will be for five years.

Potential contractors should give a capability statement about how the company would meet these requirements. 

Responses are due via email to the contracting specialist by April 19 at 3 p.m. EST.