Phase I – Clinical Development

In Phase I, the focus shifts to producing small-scale GMP material for first-in-human studies.

Our capabilities include:

• Manufacturing under cGMP with phase-appropriate controls.
• Rapid scale-up from laboratory to pilot plant using QbD and DoE principles.
• Detailed impurity and stability assessment to support clinical dosing safety.
• Flexible manufacturing slots to meet tight timelines for Phase I supply.

At this stage, Amoli ensures process reproducibility and data integrity, helping sponsors establish confidence in early human studies.

Phase II – Process Optimization & Scale-Up

Phase II focuses on refining the process and demonstrating scalability.

 

Our services include:

 

• Optimization of reaction conditions for yield and purity improvement.
• Identification of Critical Process Parameters (CPPs) and establishment of control strategies.
• Technology Transfer to pilot-scale or secondary facilities.
• Analytical validation and stability studies aligned with ICH guidelines.

Our pilot-scale facilities are designed to replicate commercial operations, ensuring seamless transition and reducing downstream risks.

Phase III – Commercial Process Design & Validation

In Phase III, the emphasis is on ensuring that the process is fully validated and ready for commercial production.

Amoli’s multidisciplinary teams execute:

• Process Performance Qualification (PPQ) and equipment validation.
• Process Validation Batches under cGMP conditions.
• Regulatory File Support, including CTD Modules and response management.
• Lifecycle and Risk Management to ensure robustness and consistency across campaigns.

Our process design and validation teams integrate scientific, quality, and engineering perspectives to ensure successful technology transfer and audit-ready documentation.