Protect (ACD&P)
Abstract
The Protect Advanced Component Development and Prototypes (ACD&P) Project provides the ability to shield the Joint Force from harm caused by Chemical Biological Radiological and Nuclear (CBRN) hazards by preventing or reducing individual and collective exposures, applying prophylaxis to prevent or mitigate negative physiological effects, and protecting critical equipment. Efforts included in this Project are: (1) Advanced System for Protection and Integration Reduction of Encumbrances (ASPIRE) (2) Accelerated Antibodies-Enhanced Biological Defense (AA-ENBD) (3) Biological Containment Isolation System - Enhanced Biological Defense (BCIS-ENBD) (4) Generative Unconstrained Intelligent Drug Engineering-Enhanced Biological Defense (GUIDE-ENBD) (5) Medical Countermeasures Platform Technologies (MCMPT) (6) Plague Monoclonal Antibodies (PLG MAB) (7) Portable Patient Transport System - Enhanced Biological Defense (PPTS-ENBD) (8) Shipboard Isolation System (SIS) (9) Vaccine Acceleration by Modular Progression-Enhanced Biological Defense (VAMP-ENBD) (10) Uniform Integrated Protective Ensemble Family of Systems Footwear (UIPE FoS Footwear) (11) Biological Warfare Defense Medical Countermeasures Prototype (BIOPROTO) The Advanced System for Protection and Integrated Reduction of Encumbrances (ASPIRE) Next Generation Respirator effort provides respiratory and ocular protection against CBRN threats that allows near normal operations in a CBRN environment by minimizing or eliminating physical and psychological burden and increasing warfighter lethality. This program, in conjunction with work by Joint Science and Technology Office (JSTO), will lay out the strategy and path forward required to minimize the burden to the warfighter while still providing respiratory and ocular protection against CBRN agents. In FY25, funding will be utilized to develop prototypes on a Countering Weapons of Mass Destruction Other Transaction Authority (CWMD OTA). The Accelerated Antibodies - Enhanced Biodefense (AA-ENBD) will develop prophylactic and therapeutic monoclonal antibody (mAb) Medical Countermeasure (MCM) against a broad range of biological threats. AA-ENBD will target the discovery, identification and small-scale manufacture of mAbs with sufficient material to support non-clinical and clinical testing. Sufficient doses will be produced and maintained for potential use in emergency response situations. AA-ENBD was formerly known as Monoclonal Antibodies Therapeutics-Enhanced Biodefense (MAB TX-ENBD). In FY25 AA-ENBD will complete phase 1 clinical studies for mAb product number 1 and initiate phase 1 trials for mAb products number 2 and number 3. The Biological Containment Isolation System - Enhanced Biological Defense (BCIS-ENBD) will provide a negative pressure shelter system for medical treatment of biologically contaminated patients in an Army field hospital environment. BCIS-ENBD will provide a ground-based isolation area for personnel infected or suspected of infection from a biological threat and allows medical staff to monitor and/or treat while decreasing the risk of infecting other patients and staff. This project was funded in FY24 under the Collective Protection CONEX-Enhanced Biological Defense (COL PRO CONEX-ENBD) effort, and was renamed BCIS-ENBD to accurately reflect the capability and applicability of the system. In FY25, BCIS-ENBD will complete concept design, system planning and conduct an initial concept demonstration. The Generative Unconstrained Intelligent Drug Engineering - Enhanced Biodefense (GUIDE-ENBD) is an intelligent drug design and engineering system intended to decrease product development risk throughout the medical countermeasure development life cycle, accelerate candidate development, and enable preemptive preparedness and rapid response. GUIDE impacts the discovery and design of biologics products (e.g., monoclonal antibodies and vaccines) and small molecule drugs through a multi-faceted optimization process capturing critical quality attributes of safety, efficacy, manufacturability, and pharmacokinetics/pharmacodynamics (PK/PI). Furthermore, GUIDE incorporates computational and experimental approaches to manufacturing controls and preclinical/clinical testing. GUIDE is a collaboration between interagency, academia, and industry partners and is integrated with the Accelerated Antibodies and RNA Vaccine Acceleration by Modular Progression (VAMP) programs. In FY25 GUIDE will continue to develop a fully integrated computational approach to accelerating medical countermeasure development. The Medical Countermeasure Platform Technologies (MCMPT) program streamlines and accelerates delivery of medical countermeasure to the Warfighter against known and emerging biological threats by establishing mature platform technologies that allow for rapid response and by reducing developmental risks. MCMPT is establishing enabling technologies and prepositioning platform systems within the Department of Defense (DoD)'s Advanced Development Manufacturing (ADM) network using standardized discovery, design, manufacturing, and testing processes to reduce the medical countermeasure (MCM) development risks. In FY25 MCMPT will continue to deliver enduring capabilities from which future candidates can be manufactured. The Plague Monoclonal Antibodies (PLG MAB) program was transitioned in FY2023 from Medical Countermeasure Platform Technologies (MCMPT) Advanced Development and Manufacturing of Antibody Technology (ADAMANT) effort. PLG MAB will provide a pre-exposure monoclonal antibody product to protect the warfighter from aerosolized plague and is intended for intramuscular route of administration. This capability is complementary to plague therapeutics and will provide a continuum of protection against plague bacteria. In FY25 PLG MAB continues monoclonal antibody discovery and half-life extensions to produce product to support a Phase 1 clinical study. The Portable Biocontainment Patient Transport System-Enhanced Biodefense (PPTS-ENBD) effort will provide a biocontainment isolation system to safely transport personnel infected or suspected of infection from a biological threat. In FY25, PPTS ENBD will begin system test and evaluation and develop logistics products. The Shipboard Isolation System (SIS) project will provide the capability to temporarily isolate or quarantine personnel to prevent the spread of a biological threat and safely evacuate patients for transfer off the ship. SIS will be used on multiple Navy ship types to contain and medically monitor/treat patients while protecting embarked crew and personnel. In FY25, SIS will release Request for Proposals (RFP), award contract for prototypes, and delivery of prototypes. The Vaccine Acceleration by Modular Progression - Enhanced Biodefense (VAMP-ENBD) will leverage lessons learned to shorten future emergency response timelines, mitigate impacts of biological threat outbreaks, and create interim capabilities to protect the Warfighter. Leveraging interagency, industry, and academia partnership, VAMP will continue to build the Warfighter's bio-armor to protect against biological threat families. VAMP will continue to develop alternative vaccine platform technologies and manage awards utilizing go/no-go checkpoints along the development pathway. The Uniform Integrated Protective Ensemble Family of Systems Footwear (UIPE FoS Footwear) will provide the warfighter with percutaneous protection against liquid, vapor, dust, particulate, or sporulated toxic material, chemical and biological warfare agents and radiological fallout particles when worn as part of the Uniform Individual Protection Ensemble (UIPE). UIPE FOS Footwear funding discontinues after FY24 due to higher priorities within the Chemical Biological Defense Program (CBDP). BIOPROTO supports early-phase clinical development and supporting non-clinical safety, tolerability and toxicity data for candidate vaccines and therapeutic drugs prior to transition to System Development & Demonstration. This work provides safe and effective medical defense against validated biological threat agents and emerging infectious disease biothreats including bacteria, toxins, and viruses. This work also involves the evaluation of Food and Drug Administration (FDA)-approved therapeutics for operational use, as well as generation of novel drug products and formulations, to enhance level of protection and/or operational utility for the Warfighter. This effort reduces programmatic risk of failure in the advanced development phase.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2025
- Source ID
- PT4_0603884BP_4_0400_PB_2025
Related Documents
- Root: Chemical and Biological Defense Program - Dem/Val
- Child Accomplishment: 1) ASPIRE
- Child Accomplishment: 2) AA-ENBD
- Child Accomplishment: 3) BCIS-ENBD
- Child Accomplishment: 4) GUIDE-ENBD
- Child Accomplishment: 5) MCMPT
- Child Accomplishment: 6) MCMPT
- Child Accomplishment: 7) MCMPT
- Child Accomplishment: 8) PLG MAB
- Child Accomplishment: 9) PPTS-ENBD
- Child Accomplishment: 10) SIS
- Child Accomplishment: 11) VAMP-ENBD
- Child Accomplishment: 12) UIPE FoS Footwear
- Child Accomplishment: 13) BIOPROTO
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