SOLICITATION NOTICE
70 -- Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services
- Notice Date
- 8/23/2024 12:21:34 PM
- Notice Type
- Solicitation
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- 75F40124Q00512
- Response Due
- 8/30/2024 12:00:00 PM
- Archive Date
- 09/14/2024
- Point of Contact
- Lilibeth Deato, Phone: 3017960349
- E-Mail Address
-
lilibeth.deato@fda.hhs.gov
(lilibeth.deato@fda.hhs.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/436cc194903f41268ce3412caf31ed0b/view)
- Place of Performance
- Address: Beltsville, MD 20705, USA
- Zip Code: 20705
- Country: USA
- Zip Code: 20705
- Record
- SN07184392-F 20240825/240823230126 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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