Trump Administ​ration launching projects aimed at revolutionizing U.S. drug manufacturing

The Trump Administration is launching four projects aimed at revolutionizing pharmaceutical manufacturing in the United States using artificial intelligence, machine learning, and informatics. The use of these technologies may enhance efficiency, lower production costs, reduce drug shortages, speed approval times for drugs manufactured using agile manufacturing technologies, and boost rapid response to national emergencies.   

The program, called Equip-A-Pharma, is a collaboration between the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR); the Defense Advanced Research Projects Agency (DARPA); and the private sector.

Over the next year, each company and its partners will aim to show how their agile technologies can potentially make active pharmaceutical ingredients and specific finished drug formulations (medications) at the point-of-care.  

“Manufacturing medicines from start to finish in the United States ensures a secure supply of essential medications,” said HHS Principal Deputy Assistant Secretary for Preparedness and Response John Knox.  “Traditional pharmaceutical manufacturing is often too rigid and slow to adapt to changing demands, especially during national emergencies. We’re launching projects aimed at completely changing the approach not just to bring pharmaceutical manufacturing back to the U.S. but to do it better.”    

The projects can also facilitate regulatory approval, by streamlining the collection and analysis of data that the U.S. Food and Drug Administration evaluates in approving drugs under its regulatory framework. 

By producing active pharmaceutical ingredients and finished medications at the point of care, such as a hospital, these types of technologies can strengthen domestic supply chains. This approach could mitigate drug shortages, ultimately enhancing national health security and resilience.   

These projects address U.S.-based manufacturing of eight (8) sterile injectable or oral medications and the active pharmaceutical ingredients for these medicines.   

The partners conducting the projects are Battelle Memorial Institute and Aprecia; BrightPath Laboratories; Rutgers University; and the Mark Cuban Cost Plus Drug Company.    
 

• Partners Battelle Memorial Institute and Aprecia are integrating advanced process analytics and machine learning that allows for real-time quality assessment and supports a digital approach to generating regulatory submissions. The companies are using their own technologies together to produce 3-D printed oral solid dosage forms (tablets) of levetiracetam to treat epilepsy or other seizures, and linezolid to treat gram-positive infections such as bacterial pneumonia.   
   
• Bright Path is demonstrating technology for continuous flow manufacturing to produce Lidocaine HCl, a local anesthetic, and Carboplatin, a chemotherapy drug. The project is expected to show enhanced efficiency, scalability, adaptability of the technology, rapid reconfiguration between products with minimal downtime, and a real-time digital approach to generating regulatory submissions. The technology integrates advanced process informatics and in-process metrology (precise measurement) to ensure consistent quality and compliance with stringent regulatory requirements.
• Rutgers University will demonstrate manufacturing of registration batches for two critical drugs, Bupivacaine HCl, an anesthetic, and Albuterol Sulfate, used to treat people with asthma, bronchitis, emphysema or other lung conditions. Rutgers has been working with ASPR’s Center for Industrial Base Management and Supply Chain and DARPA to develop an innovative, agile manufacturing platform and generating rich data sets using new AI tools that can inform future regulatory submissions and rapid release of products.
• The Mark Cuban Cost Plus Drug Company is employing a highly automated and flexible manufacturing platform that integrates AI and machine learning for real-time quality assessment and process optimization. The company is demonstrating use of the platform to process active pharmaceutical ingredients and the finished medication doses rapidly with in-line metrology (precise measurement) to produce lidocaine, a widely used anesthetic, and diltiazem, a calcium channel blocker used to treat heart conditions. The system uses AI-driven informatics, is scalable and adaptable, and can be used by operators with minimal training to maintain product quality.  

All of the partners in these projects are expected to submit Abbreviated New Drug Applications to the U.S. Food and Drug Administration within a year as a result of leveraging the government-supported development work.  

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