gPROMS lyophilization Modeling Toolbox (or equal)
Closed Solicitation Posted
A newer special notice was posted. See the latest special notice from .
- Solicitation number
- FDA-75F40126Q00155
- Agency
- FDA Office of Acquisition and Grant Services Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 513210 Software Publishers
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
-
- Terina Hicks terina.hicks@fda.hhs.gov
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA Office of Acquisition and Grant Services seeks a gPROMS lyophilization modeling toolbox license or equivalent software platform, with quotations due May 20, 2026, and questions due May 13, 2026. This is a firm fixed-price purchase order for commercial items under FAR Part 13 with lowest-price-technically-acceptable evaluation.
Place of performance is Silver Spring, Maryland. The platform must deliver nonlinear predictive control optimized for high-performance computing to model time-dependent lyophilization cycles using first-principles equations rather than empirical data. The software must include a base operational intelligence and data integration system (such as XHQ) capable of aggregating and visualizing real-time data from multiple manufacturing sources to support digital twin validation. Advanced material and thermodynamic property architecture must support complex pharmaceutical formulations through comprehensive excipient and API databases tracking moisture content and chemical purity. The platform must incorporate automated global system analysis with parameter estimation from experimental data and global sensitivity analysis to identify influential process parameters and validate Quality by Design design spaces. A customizable, equation-oriented modeling environment with a robust API for integration with external systems such as Python, Excel, and electronic laboratory notebooks is required.
The deliverable is one single-user license with a 12-month subscription, to be delivered within 30 days of award. Period of performance runs July 10, 2026, to July 9, 2027. The contractor must be either the original equipment manufacturer or an authorized reseller with documentation confirming status. Support includes email and web conference technical assistance, maintenance, system upgrades, one day of project support, and training access via Altair resources. Payment terms are net 30 days after government acceptance via the Treasury Department's Invoice Processing Platform. NAICS code 513210 applies; PSC category is DH10.
Notice text
The objective is to establish a new contract for Siemens modeling and simulation platform license, featuring advanced process modeling.
FDA's OPQR has a requirement to obtain an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. For Quoter’s software to be deemed acceptable, the following salient characteristics shall be met:
Lyophilization Modeling Toolbox
• Nonlinear Predictive Control (NL) for Lyophilization: Utilizes a highly parallelized, equation-oriented architecture optimized for high-performance computing (HPC) to perform large-scale, high-fidelity predictive modeling of time-dependent lyophilization cycles.
• Operational Intelligence & Data Integration: Must include a base system (such as XHQ) capable of aggregating and visualizing real-time operational data from multiple manufacturing sources to support "Digital Twin" validation.
• High-Fidelity Dynamic Simulation: Capable of simulating transient process events and complex equipment dynamics—including freezing, primary drying, and secondary drying—using first-principles mathematical equations rather than empirical data.
• Advanced Material & Thermodynamic Property Architecture: Supports the modeling of complex pharmaceutical formulations through comprehensive databases for excipients and APIs to track critical properties like moisture content and chemical purity throughout the stabilization process.
• Automated Global System Analysis (GSA): Built-in mathematical tools to perform parameter estimation from experimental data and Global Sensitivity Analysis (GSA) to identify influential process parameters and validate Quality by Design (QbD) design spaces.
• Customizable Modeling Environment & API: Features an open, equation-oriented language for creating custom first-principles models from scratch, complemented by a robust Application Programming Interface (API) for integration with external data systems like Python, Excel, or Electronic Lab Notebooks.
• Scalable Enterprise Access: Supports flexible licensing types including "Named User" for specific researchers and "Small System" base configurations to manage data exchange across physical or virtual assets.
• Regulatory-Grade Maintenance and Support: Provided through a multi-year subscription model that includes continuous software enhancement, technical support, and alignment with established Licensed Software Designation Agreements (LSDA).
Maintenance and Technical Support
At minimum the contractor must:
• Provide support via email and/or web conference.
• Licenses shall include maintenance, support, and any upgrades necessary to maintain the system.
• Provide one day of project support.
Training
The Contractor shall provide:
• Access to online training material in Altair resources
Please review the attached RFQ_FDA-75F40126Q00155 document for all details.
Attachments
| File | Type | Posted |
|---|---|---|
| RFQ_FDA-75F40126Q00155.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal) | Special Notice | |
| gPROMS lyophilization Modeling Toolbox (or equal) | Solicitation |
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