Procurement of a DM 20 Automated In-Line Concentration and Filtration for Bulk Drug Substance (SINGLE-PASS TFF), (Brand Name or Equal) plus four (4) option years of Preventative Maintenance Agreement (PMA)

FDA seeks to procure of an automated single pass tangential flow filtration system (SPTFF) to provide in-line concentration of harvested/clarified cell culture fluid and/or purified drug substance prior to storage. This equipment will be used in a continuous manufacturing process being developed in FDA labs and will provide a better understanding of the technology and regulatory concerns associated with this technology.The Cadence SPTFF or equivalent system shall be designed to allow for automated in-line concentration of proteinaceous solutions with minimal manual manipulations. The system will be used in a continuous manufacturing process at two potential locations: harvest and downstream post-polishing. The system should allow for automated controls (PID controls) provided by an included controller along with all pumps, pressure gauges, flow meters, sensors, and regulators required. The system should be OPC or UA compatible with our existing Lucullus software. The system shall include all filters modules and filter holders required to achieve in line concentration targets mentioned here in section 3, below. The SPTFF unit (2) shall be capable of concentrating both harvested/clarified cell culture fluid as well as purified protein solutions depending on the application needed (This may require one or more total units and pricing may limit feasibility). The system shall be capable of concentrating harvested/clarified cell culture fluid in the range of 10-60 liters per day (recommendations for filter area and pore size are welcome) from starting titers of <1g/L to 2 g/L. Additionally, this SPTFF unit shall also be capable of concentrating purified protein solutions with concentrations from 10 g/L up to 50 g/L. See attached RFQ and respond as required/ASAP or by RFQ due date.