Nimble, highly adaptable, cost effective, and safe.
The flexibility to efficiently and cost-effectively take on both small and large-scale projects.
Bright Path Labs offers customers a more agile and integrated approach to API/pharmaceutical development. Through our ability to conduct rapid experimental design, efficient mixing, expedient scale-up capabilities and quick change-over, Bright Path Labs can offer affordable, high-quality and readily available medicines. Bright Path Labs cutting-edge chemists and engineers have extensive experience in designing and optimizing processes for robustness, safety, environmental impact, and speed.
We are also flexible, efficient and cost-effective and can take on both small and large-scale projects – all while rapidly delivering innovative approaches to solve development challenges. Bright Path Labs API development services and STT® technology helps avoid late-stage process changes, which saves time and money. Bright Path Labs efforts ensure that process and product criteria meet quality and regulatory requirements as clients move from preclinical to commercial scale production.
API process development services initially include
Custom API and Intermediate route discovery, selection, and synthesis
Process definition, improvement, limits testing, and optimization
Synthesis of analytical reference standards
Rapid go/no-go feasibility evaluations of new molecules
Proof-of-concept, pre-clinical, and clinical lots
Process scale-up campaigns, pilot and commercial scale manufacturing
Process qualification, validation, and stability studies
In contrast to batch processing, Bright Path Labs end-to-end continuous manufacturing sends raw materials through an uninterrupted process until the final product is completed. Our continuous pharmaceutical manufacturing capability is poised to help address industry challenges and provide tremendous benefits, such as:
Reduced costs from smaller facility footprint and lower operating expenses
A faster manufacturing method
Safer compared to batch methods by employing more rigorous process monitoring, lower solvent usage, and less handing leading to reduced human errors
Potential for increased domestic manufacturing
Ability to respond much more rapidly to drug shortages and related challenges
Significant improvement in process quality and consistency due to the ability to maintain state of control, low residence times, and no intermediate hold steps
Reduction of stockpiles for necessary medicines, as more and more pharmaceuticals could be produced on demand
Despite a long-time acknowledgement of the benefits of continuous manufacturing in the industry, adoption has been slow and fragmented. Currently, there are only six
drugs, all small-molecule pharmaceuticals, that incorporate continuous manufacturing, but only partially and using basic technologies.
There are two primary barriers that have slowed industry’s adoption of continuous manufacturing. First, is the issue of sunk costs and entrenched operating models.
Second, is the issue of scalability. Existing continuous flow reactor technologies are not designed to readily scale from benchtop chemistry to commercial scale production.
Bright Path Labs STT® is purposefully and measurably different. Our continuous-flow reactor can produce APIs much faster and at a lower cost than traditional pharmaceutical batch processing. The unique process is also more flexible and environmentally friendly than current production practices. The AI-powered STT® process makes API production process faster, less labor intensive, and more efficient by allowing production to be increased or decreased by varying reactor run times to meet demand, significantly improving the production process while lowering costs.