Active Pharmaceutical Ingredient (API) development focuses on refining and optimizing synthetic routes to ensure scalability, sustainability, and regulatory compliance throughout the drug development lifecycle. This function evaluates and improves chemical processes to enhance yield, reduce impurities, minimize environmental impact, and ensure robustness for pilot and commercial-scale manufacturing. API development teams collaborate closely with Analytical, DQA, EHS, and CDMO partners to deliver processes that meet global regulatory standards and support efficient, reliable GMP production.
Key Deliverables
- Development and optimization of synthetic routes suitable for large-scale production
- Process robustness studies, including defining critical process parameter (CPP) and critical quality attribute (CQA)
- Impurity and genotoxic impurity (GTI) control strategies aligned with regulatory expectations
- Sustainability-focused process improvements, such as solvent reduction and greener chemistry approaches
- Scalability assessments, including yield optimization and cycle-time reduction
- Polymorph screening, including identification, control, & consistency in commercial production
- Regulatory documentation support (e.g., process descriptions, control strategies, and risk assessments for CMC filings)