Development of Key Starting Materials (KSMs) and advanced intermediates is critical to establishing a reliable, efficient, and compliant supply chain for API manufacturing. This function focuses on designing and optimizing synthetic routes for upstream intermediates, ensuring they are feasible for large-scale production and meet required purity, cost, and regulatory standards. Teams collaborate with Analytical, SCM, DQA, and CDMO partners to define specifications, build supply resilience, and support overall API lifecycle requirements.
Key Deliverables
- Route development and optimization for KSMs and advanced intermediates
- Definition of specifications (purity, impurity thresholds, physical properties) aligned with downstream API requirements
- Impurity profiling and control strategies to ensure compatibility with final API quality targets
- Cost and supply-chain optimization, including alternative sourcing strategies
- Process scalability assessments and technology transfer packages for external manufacturing partners
- Regulatory support, including justification of KSM classification and documentation for CMC filings