# Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services

Canonical: https://abierto.us/opportunities/75f40124q00512

- Solicitation number: 75F40124Q00512
- Notice type: Solicitation
- Status: Closed. Deadline was August 30, 2024 at 3:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Office of Acq Grant SVCS (75F401)
- NAICS: 541519 Other Computer Related Services
- Product or service code: 7A21 Business Application off-the-shelf software delivered by perpetual license, which also encompasses enterprise level software enabling mission capability and business operational support.
- Set-aside: Total small business set-aside
- Place of performance: Beltsville, Maryland
- County: Prince George's County (FIPS 24033). https://abierto.us/counties/prince-george-s-county-md-24033
- City: Beltsville. https://abierto.us/cities/beltsville-md-2406400
- First posted: August 23, 2024
- Last posted: August 23, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/436cc194903f41268ce3412caf31ed0b/view

## 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.

## Publications

- August 23, 2024: Solicitation, due August 30, 2024 at 3:00 PM EDT. Notice 436cc194903f41268ce3412caf31ed0b. https://sam.gov/workspace/contract/opp/436cc194903f41268ce3412caf31ed0b/view

## Points of contact

- Lilibeth Deato, lilibeth.deato@fda.hhs.gov, 3017960349

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/75f40124q00512.