API Process Development and Optimization

API process development is the systematic design and optimization of a synthetic route to manufacture an active pharmaceutical ingredient. It ensures that the process is efficient, reproducible, economical, safe, and environmentally friendly, while meeting regulatory standards. Proper development reduces scale-up risk and enables consistent production of high-quality drug substance.

We evaluate multiple pathways based on criteria including cost of goods, safety, atom efficiency, IP position, and scalability. Route scouting involves literature review, retrosynthetic analysis, and expert assessment to select the most promising route for further optimization. Selection is project-specific and reviewed with your team.

Yes, our service includes scale-up from laboratory to pilot scale and technology transfer to your manufacturing partner. We prepare batch records, train personnel, and support the first batches (if scoped). The level of support is defined during consultation to match your program's needs.

We conduct process safety assessments including reaction calorimetry, differential scanning calorimetry (DSC), and thermal stability studies. These evaluations identify thermal hazards and help define safe operating conditions, preventing incidents during scale-up. Safety data is documented in the process package.

Yes, we provide optimization services for existing processes to improve yield, reduce cost, or address quality issues. Our approach involves analyzing current CPPs, conducting targeted DoE studies, and recommending changes to enhance robustness and efficiency. The scope is tailored to your specific objectives.