Inactive Total Small Business Set-Aside (FAR 19.5)

The Office of Biotechnology in the Food and Drug Administration’s CDER currently has an integrated cell culture process in the continuous manufacturing (CM) system for a model therapeutic protein drug... The Office of Biotechnology in the Food and Drug Administration’s CDER currently has an integrated cell culture process in the continuous manufacturing (CM) system for a model therapeutic protein drug product. CDER currently lacks a system to integrate the manufacturing steps required to purify therapeutic protein drug product from the harvested cell culture bioreactor material in the CM process. As a result, CDER requires a purification system to support the integration of an automated, synchronous purification schematic into continuous manufacturing of a model therapeutic protein drug product.