Process Chemistry:Targeting economical, safe, robust and reliable manufacturing process while balancing process R&D with the clinical drug development stage to reduce time and cost by: ·Designing new synthetic routes to exploratory compounds; ·Developing & optimizing a manufacturing process for enhancing IP; ·Identifying low-cost, reliable sources of materials and key intermediates ·Transferring process technology to commercial manufacturing. Custom Preparations:Synthesizing mg to kilo quantities of compounds for: ·Medicinal chemistry compounds ·Pre-clinical development candidates ·Reference standards ·Drug metabolites ·Degradant standards cGMP/GLP Analytical Services: Providing analytical chemistry as an integral component of cGMP and GLP operations supporting regulatory filings. Internal capabilities and partnerships with external laboratories include: ·Analytical method development, verification and validation; ·In-process monitoring; ·Release testing of raw materials and process intermediates; ·cGMP release testing; ·Accelerated and long-term drug substance and product stability; ·Identifying & characterizing process impurities & degradants; ·CMC documentation for IND, NDA and ANDA filings. Commercial cGMP Manufacturing: Integrated CMC support culminates with: ·Supplying raw materials & manufacturing bulk key intermediates; ·Conducting commercial-scale process validation batches; ·cGMP production of kilo & tonage quantities of key intermediates & APIs.
