Enabling Investments (ACD&P)
Abstract
The Enabling Investments Advanced Component Development and Prototypes (ACD&P) Project maintains the Department of Defense (DoD) advanced development manufacturing facility to rapidly develop, manufacture, and approve medical countermeasures. Enabling efforts in this area support dedicated infrastructure capabilities, demonstrations, and overarching development support functions as portfolio enablers responding to emerging threats. Priority access to the facility provides an on demand manufacturing capability not only for the DoD but for the entire United States Government enterprise. In FY 2023, the Chemical Biological Defense Program (CBDP) RDT&E Projects were restructured to align with the CBDP portfolio construct. EN4 efforts in FY 2022 remain in Project MB4. This restructuring provided standardization and alignment across CBDP research, development and acquisition efforts. Efforts included in this Project are: (1) Chem Bio Incident Preparedness and Response - Advanced Development and Manufacturing (CBIPR-ADM) (2) Medical Countermeasures Manufacturing Optimization (MCM MFRO) The CBIPR-ADM ensures prioritization to domestic biopharmaceutical manufacturing capacities, capabilities, and infrastructure (e.g. the DoD-ADM Facility and other strategic partners) that are operationally ready to rapidly develop and manufacture medical countermeasures (MCMs) against current and emerging chemical and biological threats including pandemic response. Prioritization is achieved by establishing and enhancing proven biopharmaceutical manufacturing platform technologies and infrastructure at these facilities. Thus, these facilities will have the capability to accelerate development of MCMs at all stages of development, enhance preparedness for existing threats, and rapidly respond to emerging threats as part of a medical integrated layered defense. MCMs that benefit from these efforts include: Vaccines for Viral Agents, Vaccines for Bacterial Agents and Toxins, monoclonal antibodies, antibody fragments and conjugates for therapeutic and prophylactic use across all agent classes. Funds to support prioritization and operational readiness were previously provided via individual product development and manufacturing funding lines. The Department is now providing dedicated funds. The CBIPR-ADM return on investment is an increased level of preparedness and responsiveness. In FY24, the CBIPR-ADM program continues to establish and enhance new manufacturing platform technologies and infrastructure that will enable the development of MCMs against chemical and biological threats. The MCM MFRO postures the DoD to rapidly respond to biological incidents by leveraging partners across Industrial Base, Chemical and Biological Defense Program, and Defense Health Program to reduce time required to onshore materials critical to the rapid production of medical countermeasures. Furthermore, MCM MFRO will increase the use of computational tools and manufacturing controls to optimize development of MCMs for accelerated delivery to the Warfighter. In FY24, MCM MFRO will increase usage of computational tools and manufacturing controls, initiate optimization of cell productivity, initiate development of starting materials and conduct a process efficiency study.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2024
- Source ID
- EN4_0603884BP_4_0400_PB_2024
Related Documents
- Root: Chemical and Biological Defense Program - Dem/Val
- Child Accomplishment: 1) CBIPR-ADM
- Child Accomplishment: 2) MCM MFRO
- Child Accomplishment: 3) MCM MFRO
- Child Accomplishment: 4) MCM MFRO
- Child Cost Item: c6abe9377c4973599def97a367f2e97d
- Child Cost Item: 9f8f2dc87e5d6019a38331e169e66a35
- Child Cost Item: 9aa5fc964f160053256c16da9a3a42f3
- Child Cost Item: 404ed5f4b825df185cda49879d0339c2