| RPP # (Date) | Requirement Topic | Description | Requiring Office | Submission Due Date |
|---|---|---|---|---|
| Draft Statement of Objectives (08/18/2025) | Draft Statement of Objectives (SOO) for Monoclonal Antibody (mAb) Advanced Manufacturing Capability Improvement: Smart Manufacturing | Monoclonal Antibodies (mAbs) played a central role in the US response to the outbreaks of important human pathogens such as anthrax, Ebola, RSV or SARS-CoV-2. Building on the demonstrated manufacturing performance of mAbs for a rapid response, BARDA is seeking to improve (enhance) the speed and efficiency of mAb production. This effort is directed at developing and implementing FDA Advanced Manufacturing goals within the mAb therapeutic manufacturing environment. The FDA’s goals for this program are to improve drug quality, address shortages of medicines, and speed time-to-market. Innovations that rapidly scale manufacturing capabilities, create a distributed network of manufacturing sites improving the cost-efficiency of manufacturing processes and new tools that can address drug shortages by improving are identified to support the emergency preparedness and response mission of the Biomedical Advanced Research and Development Authority (BARDA). | BARDA | 09/01/2025 |
| Market Research Survey (08/06/2025) | Market Research Survey: Personal Protective Equipment Manufacturing | The BioMaP-Consortium is conducting a market research survey on behalf of ASPR's Center for Industrial Base Management and Supply Chain (IBMSC) to better understand current U.S. manufacturing capabilities for personal protective equipment (PPE). Manufacturers of Man-made fibers, Man-made fabrics, Nitrile gloves, N95 respirators or masks, Nitrile butadiene rubber (NBR) are encouraged to respond. | IBMSC | 8/19/2025 |
| Type | Release Date | Requirement Topic | Closed Date |
|---|---|---|---|
| Market Research | 03/26/2025 | Market Research survey for Adherent Cell Culture Manufacturing | 04/09/2025 |
| Market Research | 11/07/2024 | Market Research Survey for Pichia Expression System Capabilities | 11/21/2024 |
| Request for Information | 03/20/2024 | Request for Information regarding Manufacturing Optimization for Filovirus Human Monoclonal Antibodies | 04/20/2024 |
| RPP-24-05-N95 | 08/02/2025 | Sustainment of N95 Respirator Manufacturing Capacity | 08/22/2024 |
| RPP-24-07-mAbs | 06/24/2024 | Manufacturing Optimization for Filovirus Monoclonal Antibodies | 08/05/2024 |
| RPP-24-06-Pipette | 06/27/2024 | Industrial Base Expansion of injection molded pipette tips and centrifuge tubes for use in the vaccine manufacturing and pandemic response supply chain | 07/25/2024 |
| RPP-24-03-Sterilization | 03/01/2024 | Sterilization Capacity for Vaccines and Therapeutics | 03/28/2024 |
| RPP-24-02-KSM-API | 02/21/2024 | Production of Drug Substances and Drug Products at Commercial Scale | 03/20/2024 |
| RPP-24-01-SmallMol | 01/11/2024 | Production of Biologically Derived Small Molecule Regulatory Starting Materials and/or Active Pharmaceutical Ingredients at Commercial Scale | 02/01/2024 |
