Antibody (Ab) Advanced Manufacturing Capability Improvement: Smart Technologies
Closed Special Notice Posted
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- Place of performance
- Summerville, South Carolina, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response has issued a Special Notice seeking antibody advanced manufacturing capability improvements through smart technologies. This opportunity focuses on enhancing monoclonal antibody (mAb) production capabilities, building upon their critical role in responding to outbreaks of anthrax, Ebola, RSV, and SARS-CoV-2. The Biomedical Advanced Research and Development Authority (BARDA) is leading this initiative to improve the speed and efficiency of antibody manufacturing processes. The Special Notice was posted on September 10, 2025, with responses due by October 1, 2025. This solicitation does not utilize any set-aside preferences and is open to all qualified contractors.
The primary objective is to develop and implement FDA Advanced Manufacturing goals within antibody manufacturing environments, with particular emphasis on innovations that enhance scalability, create distributed manufacturing networks, improve cost-efficiency, and address drug shortages for emergency preparedness. BARDA seeks solutions incorporating automation, digitization, and artificial intelligence to streamline production methods, enhance process control data collection, and deploy smart algorithms for adaptive production control and decision-making. Any proposed improvements must demonstrate applicability across multiple biologics and focus specifically on manufacturing enhancements for products within the BARDA portfolio. The initiative aims to advance beyond current mAb manufacturing performance to support rapid response capabilities for future public health emergencies. Strategic oversight for resulting Project Agreements will be provided directly by BARDA, ensuring alignment with national biodefense and emergency preparedness objectives.
Notice text
Monoclonal Antibodies (mAbs) played a central role in the US response to the outbreaks of important human pathogens such as anthrax, Ebola, RSV and SARS CoV-2. Advancing beyond the demonstrated manufacturing performance of mAbs for a rapid response, BARDA is seeking to improve (enhance) the speed and efficiency of antibody production. This effort is directed at developing and implementing FDA Advanced Manufacturing goals within the antibody manufacturing environment. Innovations of most interest are those that rapidly scale manufacturing capabilities (scalability), create a distributed network of manufacturing sites (portability), improve cost-efficiency of manufacturing processes, and create new tools that can address drug shortages in support of the emergency preparedness and response mission of the Biomedical Advanced Research and Development Authority (BARDA).
Improvements of consideration in this solicitation apply the use of automation, digitization, and artificial intelligence to; streamline production methods, collection of more process control data, and ultimately design and deployment of smart algorithms that adaptively control or make decisions about production or release. The effort must be directed at an improvement which can be used across multiple biologics (applicability).
The effort must be focused on the manufacturing improvement of a product in the BARDA portfolio.
Strategic oversight for the Project Agreement(s) supported by this RPP will be provided by BARDA.
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA) | Office of the Assistant Secretary for Preparedness and Response | No set-aside | |
| BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003) | Office of the Assistant Secretary for Preparedness and Response | No set-aside |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity