Bright Path Labs

Bright Path Laboratories, Inc. (“BPL”) is an advanced drug development and manufacturing company that is working in partnership with the U.S. FDA Emerging Technology Team (“ETT”) to deploy advanced continuous manufacturing (“CM”) technologies. BPL chemists and engineers pioneered and patented use of our innovative continuous flow Spinning Tube-in-Tube (STT®) reactor for process intensification across a wide range of chemistries and demonstrated this capability to the FDA to advance the implementation of continuous manufacturing of active pharmaceutical ingredients (“APIs”) for the industry. The STT® reactor’s unique two-dimensional rotating flowing film environment generates a well-mixed solution that improves mass and heat transfer, which not only accelerates chemical reactions, but also expands the window of novel synthetic routes. The new routes are more well-controlled; often proceeding at lower temperatures, in reduced or solventless conditions, and using less toxic and stringent chemicals when compared to the traditional, volume-based, batch chemical production methods widely used today. Our development team of process intensification experts specialize in rapidly translating complex, multi-step synthetic processes from batch into simple continuous processes. Simultaneously, our pharmaceutical development and manufacturing team begins process design, validation planning, technology transfer, and CMC package preparations to support NDA, ANDA, and DMF filings, if applicable. Our full BPL Continuous Processing STT® Reactor Platform is Artificial Intelligence (AI)-enabled. It has capabilities to run 24/7 to rapidly explore alternative chemical routes, survey the synthetic pathway design surface boundary and optimal conditions, which are carried forward to define and validate production process parameters. Process conditions translate directly to different reactor sizes within the same Platform allowing customers to effortlessly scale up, down, or out. Recently, BPL has developed real-time process monitoring and control capabilities including quality management system integration, allowing tight control of processes, instantaneously responding to deviations in order to maintain control over ideal process conditions. If process excursions begin to occur, the reaction can be corrected through AI/ML closed-loop control, and then immediately halted and corrected without creating large volumes of unusable material. Our full BPL Continuous Processing STT® Reactor Platform is also Quality Management System (QMS)-enabled. Taken together, our approach and Platform are designed to facilitate adoption of multiple advanced technologies as requested directly by the U.S. FDA program for Modernization of U.S. Pharmaceutical Manufacturing. We reduce risk by cutting time, complexity, and cost out of development and tech transfer work across pre-clinical, clinical, launch, routine, and late commercial manufacturing of the pharmaceutical life cycle in order to get much needed medicines to more patients more rapidly.