Dr. Yuan-An Liu

• Five-month hands-on experience in US FDA, EMA approved sterile injectable facility. • General knowledge regarding aseptic processing, including sterilization, aseptic filling and their qualifications. • Experience in international regulatory inspections. • Experience in design for a new sterile injectable plant.

Lyophilization Process Development: • Experience in API lyophilization cycle development, including thermal analysis, cycle optimization and scale-up. Process Development and Scale-up: • Knowledge in process engineering, such as practices for scale-up and for unit operations. • Experience in leading process optimization, scale-up evaluation, and trouble-shooting to complete Process Performance Qualification for a newly FDA approved API.