Process Development

Process Optimization and Validation

At Amoli CDMO, process optimization is at the core of how we build efficiency, sustainability, and reliability into every project. Our goal is to enhance process performance and maximize atom economy at each stage of development.

Through systematic analysis and intelligent redesign, we identify and remove non-value-adding steps, minimize waste generation, and improve overall yield and consistency. A dedicated cross-functional team of scientists and engineers continuously monitors and refines our processes using data-driven methodologies and advanced digital tools.

Process Validation

Our Quality Assurance and Validation teams collaborate from the earliest design stages through commercial production, ensuring every process consistently delivers high-quality, reproducible outcomes — batch after batch.

Amoli follows a structured three-stage validation lifecycle, encompassing:

1. Process Design and Qualification – Comprehensive documentation, facility design, and equipment qualification, coupled with Process Performance Qualification (PPQ) to confirm scalability and reproducibility.
2. Verification and Risk Assessment – Utilization of Design of Experiments (DoE), risk analysis, and pilot-scale verification runs to predict performance at commercial scale.
3. Continuous Process Monitoring – Ongoing data collection and trend analysis to maintain process control and ensure long-term reliability.

Our pilot plant mirrors our commercial manufacturing environment, with standardized equipment and robust Management of Change (MoC) systems. This structure enables seamless technology transfer and ensures smooth project progression from development to production.

We also offer genotoxic impurity evaluation and nitrosamine risk assessments, supporting customers in identifying and controlling potential impurities from the early stages of development.