Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services
Closed Solicitation Posted
- Solicitation number
- 75F40124Q00512
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541519 Other Computer Related Services
- Place of performance
- Beltsville, Maryland 20705, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services, Food and Drug Administration, Office of Acquisition and Grant Services is seeking to procure a mechanistic chromatography modeling software solution, including licenses, support, and maintenance services. The key requirements include a modeling environment with a graphical interface, libraries for different chromatography modes, seamless integration with AKTA systems, visual tools for quality by design, and the ability to create custom models, estimate parameters, perform sensitivity analysis, and run optimization. The contract will be awarded on a lowest-priced technically acceptable basis, and quotes are due by August 30, 2024.
This opportunity is set aside for small businesses. The contract will be a firm-fixed-price order with a 1-year base period and two 1-year option periods. The place of performance is Calverton, MD 20705, USA. No incumbent or current contractor information is provided, and the potential award value or budget range is not specified.
Notice text
Mechanistic chromatography modeling software
• Mechanistic modeling environment for conventional pharmaceutical processes including a graphical interface with drag and drop functionality.
• Mechanistic model libraries including different adsorption isotherms that can be applied to different mode of chromatography such as Affinity, Ion-exchanger, HIC, mixed-mode...
• Mechanistic model libraries for membrane separation
• Streamlined modeling workflow from calibration experiments to simulation.
• Seamless lab integration through optimal linking to AKTA system and UNICORN software.
• Visual tools for easy interpretation of simulation outputs to support the fulfilment of quality by design obligation.
• Component-centric data structure enables plug and play with different methods, system parts, and columns.
• Collaboration and knowledge management shared databased within and between projects.
• Tamper-proof and back-traceable data and user management
• Simulates preparative liquid chromatography processes with a computer.
• Creates digital twins of downstream processes using mechanistic models.
• Enables increased process understanding for smarter and faster process development.
• Applies to a wide range of molecules and applications from early process development to late stage, scale-up, troubleshooting; and chemistry, manufacturing, and controls (CMC)
• Custom modeling capabilities to create user defined models.
• Parameter estimation from experimental data to support model validation.
• Global sensitivity analysis to analyze the impact of inputs, and model parameters on process outputs.
• Ability to estimate physical properties of components using only a few experiments.
• Ability to run optimization and characterization.
Review the attached SOW for full description of the requirement.
Files
| File | Type | Posted |
|---|---|---|
| RFQ.pdf |
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