Bright Path Labs (BPL) is a biopharmaceutical company focused on developing and manufacturing small-molecule drugs while reshoring American pharmaceutical production. The U.S. is currently facing a severe generic drug shortage, leaving millions of Americans struggling to afford essential medications. Approximately 80% of key starting materials and active pharmaceutical ingredients are sourced from foreign countries, and supply chain disruptions and material shortages are making life-saving treatments increasingly scarce. BPL aims to enhance oversight, ensure sustainability, and improve the availability of affordable medicines. Their proprietary Spinning Tube-in-Tube (STT) reactor plays a key role in their continuous manufacturing approach, enabling faster and more scalable generic drug production. This project examined regulatory pathways for Abbreviated New Drug Application (ANDA) submissions and continuous manufacturing to address generic drug shortages. BPL seeks to streamline the ANDA submission process, ensuring compliance with regulations while identifying areas for improvement.

Our first objective, completed in the first semester, involved researching FDA ANDA guidelines, submission methods, and future regulatory requirements. After discussions with the FDA, BPL is refining its focus on manufacturing generic products. Our second objective centered on investigating agile manufacturing opportunities and optimizing continuous manufacturing. Our third objective involved identifying AI vendors to support ANDA submissions, particularly for structured content. To gain industry insights, our final objective included a survey and interviews on AI adoption and agile manufacturing, synthesizing key findings. By advancing these initiatives, Bright Path Labs aims to enhance regulatory efficiency, explore innovative manufacturing models, and leverage AI for streamlined ANDA submissions.