Discover how BioDuro transformed a critical oncology drug candidate' s development path from early toxicology to GMP readiness. Facing significant scale-up challenges, our Process R&D team delivered a streamlined, high-yield process that accelerated timelines and eliminated critical bottlenecks—all while ensuring compliance and manufacturability.

Key Highlights

• Phase-Appropriate Strategy: Seamlessly bridged Dose Range Finding (DRF) to GMP Enabling.
• Accelerated Timelines: Delivered 200 g DRF batches in just 11 weeks.
• Cost & Efficiency Gains: Slashed synthesis steps by >50% (15→7) and boosted yields (<0.1% to 15%).
• Risk Mitigation: Ensured robust, scalable processes ready for clinical trials.

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