Delivering unparalleled responsiveness and fast-tracked regulatory approvals.
Bright Path Labs patented continuous-flow platforms for synthetic chemistry are fully approved by the FDA. Further, our integrated in-line analytics delivers high volume, real-time information on reaction progress, catalytic activity and stability, along with many other key data points. With these unique tools, Bright Path Labs has the power to influence the reaction progress and selectivity amplify the optimization process, thus constituting a dial-a-molecule digital-synthesis approach.
Our STT® continuous-flow reactor and platform drives rapid synthetic route development and highly automated, controlled and inexpensive deployment of scaled cGMP commercial manufacturing. Bright Path Labs works closely with the FDA, EPA and industry leaders in AI and ML technologies ensuring that our facilities have the highest regulatory compliance, lowest environmental impact and smallest manufacturing footprint on the planet.
Most important, Bright Path Labs technology drives down the costs of life-saving drugs and delivers a distributive, domestic network of modular manufacturing facilities and a wide range of on-demand medicines.
Bright Path Labs chemists and engineers pioneered and patented our innovative continuous flow 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 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.
Bright Path Labs development team of process intensification experts specialize in rapidly translating complex, multi-step synthetic processes from batch into simple continuous processes.
Simultaneously, the pharmaceutical development and manufacturing team begins process design, validation planning, technology transfer, and CMC package preparations to support NDA, ANDA, and DMF filings. Together with partners and in collaboration with the customers, Bright Path Labs engages with the FDA’s ETT to accelerate a successful FDA submission review and approval process.
The Bright Path Labs Continuous Processing STT® Reactor Platform is 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 providing the ability to effortlessly scale up, down, or out.
Bright Path Labs 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.
Bright Path Labs Continuous Processing STT® Reactor Platform is also Quality Management System-enabled.
Taken together, Bright Path Labs approach and Platform are designed to facilitate adoption of multiple advanced technologies as requested directly by the 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 to get much-needed medicines to more patients more rapidly.