Accelerated IND Support for First-in-Human (FIH) Study
In just two months, our team successfully executed a rapid tech transfer involving two GMP manufacturing steps. We completed process optimization, demonstration batches, analytical method validation, a full GMP campaign, and API release—all under an aggressive timeline.
Our ability to mobilize cross-functional expertise and deliver with speed and precision enabled our Sponsor to meet critical IND filing milestones and stay on track for a First-in-Human study.
Result: End-to-end API development and release in record time—without compromising quality or compliance.
Sustainable Scale-Up with Enhanced Efficiency
Following a successful first GMP delivery, we continued to optimize the process with a focus on sustainability and cost-effectiveness. Through targeted development, we significantly reduced the Process Mass Intensity (PMI), making the synthesis greener and more economically viable.
As a result, we successfully manufactured 17 kg of API in a single batch using a 250 L reactor—demonstrating our capability to scale efficiently while maintaining high quality and environmental responsibility.
Outcome: High-yield, environmentally conscious API production with seamless transition from early-phase to scale-up.
Strategic Execution from Discovery Route to GMP in 5 Months
From project kickoff, our experienced team established a phase-appropriate development strategy with a clear line of sight to GMP delivery—ensuring speed without compromising quality.
Starting from a four-step discovery chemistry route with low yield, we rapidly advanced process development, produced the GLP tox batch, and successfully delivered the first GMP API batch. The entire journey—from initial planning to GMP release—was completed in just five months.
Result: Accelerated API development with strong technical execution, enabling our Sponsor to stay on track for critical program milestones.
