Automation and Integration of Downstream Biomanufacturing Licenses, Software and Maintenance

Automation and Integration of Downstream Biomanufacturing Licenses, Software and Maintenance This is a combined/synopsis solicitation issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote Background The Division of Product Quality research is seeking a flexible state-of-the-art software and process management platform for integration and control of unit operations of a pilot scale continuous biomanufacturing line. The process control system shall be modular with an open architecture that allows several unit operations and process analyzers to be incrementally added, removed, or replaced Objective To purchase a flexible state-of-the-art software and process management platform for integration and control of unit operations of a pilot scale continuous biomanufacturing line ​​​​​​​ Salient Characteristics Shall be capable of integrating unit operations of biomanufacturing process , specifically a bioreactor, all-in-one continuous capture, and polishing chromatography (Contichrome Cube), Integrated Continuous Purification System (such as PakBio), Simulated Moving Bed chromatography, Akta FPLC, and a Single-Pass Tangential Flow Filtration Modules. Shall be upgradable to include monitoring and control of individual unit operations in a continuous biomanufacturing line with tools such as HPLC, SEC-MALs, LC/MS, etc. Shall include all functions needed for data management specifically, real-time data acquisition and integration into process models, Multivariate Data Analytics and real time process monitoring and control Shall be easy to use with a highly intuitive operator interface Shall allow operation and control of the biomanufacturing process from a single interface Shall synchronize the time on all connected instruments via a domain controller Shall allow a seamlessly integration of multiple process sensors and process analytical technology (PAT) when needed The control system shall control the flow of the line(s) and connect the smart unit operations together Shall be capable of controlling non-smart equipment, such as scales, pumps, sensors, and valves Shall provide a visual overview and process graphics of the biomanufacturing line Shall notify operator of necessary interactions, loss of process control and process failure Shall allow diversion of material in case of deviation or process failure The process control system shall include all hardware, software, software licenses and engineering services required for integration of unit operations Shall include engineering services to integrate the polishing chromatography (Contichrome Cube), Integrated Continuous Purification System (such as PakBio), Simulated Moving Bed chromatography, Akta FPLC, a Single-Pass Tangential Flow Filtration Modules, and associated pumps, scales, sensors, and valves with the process control system.