Description
The FDA is seeking to obtain an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. The platform should have certain features such as nonlinear predictive control, operational intelligence and data integration, high-fidelity dynamic simulation, and advanced material and thermodynamic property architecture. The contractor will provide maintenance, technical support, and training. The contract will be for a 12-month period.
Some of the key features of the platform include:
• Nonlinear Predictive Control (NL) for Lyophilization
• Operational Intelligence & Data Integration
• High-Fidelity Dynamic Simulation
• Advanced Material & Thermodynamic Property Architecture
• Automated Global System Analysis (GSA)
• Customizable Modeling Environment & API
• Scalable Enterprise Access
• Regulatory-Grade Maintenance and Support
Attached files
Contact
Terina Hicks(Contract Specialist)