Graduation Year

2025

Date of Submission

4-2025

Document Type

Campus Only Senior Thesis

Degree Name

Bachelor of Arts

Department

Science and Management

Reader 1

Anna Wenzel

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2025 Jack T Potter

Abstract

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 sourced from foreign countries, 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. This project examines 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. We learned that average approval times for ANDAs is 4x longer than for New Drug Applications (NDAs), although changes to priority review should help BPL. Our second objective involved identifying AI vendors to support ANDA submissions, particularly for structured content. We identified two AI vendors that we believe together will help optimize BPL ANDA generation process. Our third objective centered on investigating pharmaceutical trends within agile manufacturing, continuous manufacturing, and process analytical technology (PAT). We identified precedent examples of continuous flow and agile manufacturing approval, the primary regulatory risks for agile manufacturing, and Raman and near-infrared spectroscopy as strong real-time release testing technologies for continuous flow. Our final objective included a survey or interviews on AI adoption and agile manufacturing, synthesizing key findings. During our engagement we helped BPL enhance regulatory efficiency, explore innovative manufacturing models, and leverage AI for streamlined ANDA submissions.

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