Lab & Pilot Scale
DempoChem draws on proven expertise from 300+ clinical programs to deliver customized manufacturing solutions aligned with your drug development journey. From preclinical formulation to commercial scale-up, our stage-specific methodologies ensure cGMP-compliant production with risk-mitigated workflows that maintain product integrity.
Expert Manufacturing Support
DempoChem's 20+ strategic alliances with global innovators have enabled us to refine GMP-certified manufacturing platforms spanning registered starting materials (RSMs), advanced intermediates, and APIs. This collaborative ecosystem supports therapeutic programs across neurology, oncology, and rare diseases, with dedicated containment technologies for high-potency compounds.
Our accelerated development pathway delivers cGMP materials for early-phase trials within 14-week lead times. Cross-functional teams execute QbD-driven process development from lead optimization through IND-enabling studies, integrating:
· Phase-appropriate process characterization (DoE-based)
· ICH-compliant analytical method lifecycle management
· Closed-system isolator technology for potent API handling
· End-to-end cold chain solutions (-70°C storage/distribution)
Comprehensive Supply Network and Scalable Manufacturing
DempoChem leverages an extensive supplier network to meet increasing demand as candidates progress through clinical stages. With multiple cGMP-certified sites, we can manufacture at various scales, from grams to metric tons. Our structured project management approach ensures consistent guidance and continuity throughout the program's lifecycle.