Inactive Total Small Business Set-Aside (FAR 19.5)

The Office of Biotechnology in the Food and Drug Administration’s CDER currently has a semi-purification process in the continuous manufacturing(CM) of a model therapeutic protein drug product using o... The Office of Biotechnology in the Food and Drug Administration’s CDER currently has a semi-purification process in the continuous manufacturing(CM) of a model therapeutic protein drug product using one pilot-scale PAK System Continuous Manufacturing instrument. CDER requires a bench-scale PAK System Continuous Manufacturing instrument to support an automated, synchronous purification schematic in the continuous manufacturing of a model therapeutic protein drug product. The PAK System Continuous Manufacturing instrument shall be capable of interacting with the currently FDA/CDER owned PAK System Continuous Manufacturing instrument to operate end-to-end continuously with automated controls for simultaneous operation of purification steps as well as allow for feedback control of the continuous purification process through PAT instrumentation.