During the Covid-19 Coronavirus pandemic the critical importance of personal protective equipment (PPE) was highlighted for the protection of physicians and other healthcare providers, Ironically, PPE was one of the first shortages healthcare organizations faced, as hospitals and medical offices were simply not ready or equipped for the surge in cases and the congruently increased demand for protective equipment.
But PPE has been critical beyond just the Covid-19 pandemic in a variety of Chemical and Biological (CB) threats and other contagious diseases, protecting rescue workers and first-responders in precarious environments, and shielding armed forces and military personnel from dangerous exposures are just a few examples of why PPE has been a critical aspect of human health innovation.
The current Chemical and Biological (CB) threat environment consists of broadly acting, highly pathogenic, and sometimes immediately lethal threats that are capable of entering the body via multiple pathways, including skin, airway, ocular, and the gastrointestinal tract. Despite substantial financial investments and advances in the CB Defense enterprise over many decades, current personal protective
equipment (PPE) solutions add logistical, mobility, and thermal challenges to the warfighter/stability operations care provider, which place their missions at risk.
For example, typical PPE consists of cumbersome suits and respirators that require assistance and infrastructure for proper donning and doffing, and decontamination procedures to avoid contamination from agents that may still be present on the PPE. In a humanitarian assistance setting, the hours needed to don, doff, and decontaminate PPE leaves roughly two hours in an eight hour work day for a care provider to spend with patients, as seen in the Ebola 2014 (West Africa) and 2017 (Congo) outbreaks.
These procedures limit the efficacy of stability operations workers in pandemic outbreak scenarios. Even with standard decontamination procedures and protective measures in place, hundreds of care providers have been infected with life-threatening biological agents, ranging from Ebola to Tuberculosis, due to PPE failures.
In a military context, standard military PPE constrains vision, mobility, and “time on target,” thereby negatively impacting warfighter lethality. Moreover, PPE is not instantaneously available for individuals operating in austere or poorly resourced environments with no logistics infrastructure. Finally, current PPE is not designed with a robust second line of defense, should the outer layer(s) fail. Current, second-line technology includes topical treatments that are applied after agent exposure or that simply block but do not neutralize threat agents during exposure; these treatments are not designed to work in concert with existing PPE. Rather, the state-of-the-art strategy has been to build thicker, heavier, and more logistically burdensome PPE.
The Personalized Protective Biosystem program “kicked off” in March 2021 and is exploring how to reduce discomfort while using protective equipment, Peter Highnam, the acting director of the Defense Advanced Research Projects Agency, said at the National Defense Industrial Association’s Pacific Operational Science and Technology conference. “If you ever had to put on that bio gear, you understand how important it is to wear it properly, how cumbersome it is, how hot it is,” he said. Researchers will explore how to “radically” cut down on the amount and bulk of the equipment, he said.
Eric Van Gieson, program manager at DARPA’s Biological Technologies Office, said in addition to reducing the weight of protective materials, the program will “leverage molecular components or commensal organisms at key points of vulnerability” to limit burden on users. Commensal organisms are bacteria found on the surface of the body that are harmless, and sometimes beneficial. “Successful PPB technologies would therefore change how the military and public health communities perform in unpredictable threat environments,” he said on the agency’s website.
PPB program is to develop an integrated ensemble that simultaneously eliminates protective equipment needs while increasing protection for the individual against all CB threats. The goal of the Personalized Protective Biosystem (PPB) program will develop an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. The capability to provide unburdened CB protection will reduce the logistical burden on the warfighter, provide operational flexibility, extend mission duration and sustain military operations in remote theaters, which may include diverse, unpredictable, and unknown threats.
The protective products currently in use, biological or otherwise, focus on one-threat countered by one-countermeasure, are not intrinsically adaptable, and rely on bulky, thick materials with respirators/ocular protection for sensitive tissue barrier protection. The PPB program will
provide a dynamic response to multiple threats in a way that takes cues from natural systems capable of protecting against a diverse array of threats. For example, shark skin’s inherent anti fouling capabilities can be harnessed by mimicking the shark skin-texture on a wide variety of materials for antimicrobial applications. Further, bacterial communities that currently live in the human body can sense and respond, protecting against environmental bacterial and fungal infection. Molecular, nano, and other material solutions, when coupled with lessons from natural systems, will be integral for PPB technologies to protect against current and future CB threats.
PPB will consist of lightweight materials that protect the warfighter from exposure to any CB threat while simultaneously providing a second layer of protection, at the tissue barrier, with bio-molecular, commensal organisms, or other technologies that protect the skin, eyes, and airway from CB threats. PPB will improve mission execution by solving the current (“state of the art”) protective equipment limitations including threat-specific vulnerabilities, thermal/logistical burdens, exposure risks during equipment removal/decontamination, and on-demand availability during unexpected threat situations.
The PPB program is directed at providing a two-part solution to support the individual in the following operational scenarios: (a) mission execution with minimal to zero logistical footprint, while engaging in an unanticipated multiplexed threat environments; and (b) humanitarian assistance and disaster relief (HADR) during pathogenic outbreaks in austere environments without logistical support.
The PPB program is structured as a five (5) year effort consisting of three (3) phases: (Phase I (Base), Phase II (Option One), and Phase III (Option Two)).
The PPB program envisions two technical areas (TAs) for development under this BAA. TA1 technologies will prevent contact between the body and CB agents using protective, smart materials with near-zero logistical burden. TA2 technologies will neutralize threats at vulnerable tissue barriers using a configurable BCM.
TA1 Prevent contact:
Performers will develop materials that, when applied or worn, prevent the wearer from coming in contact with CB threats, while reducing donning processes to less than 10 minutes to provide full body coverage. Additionally, these TA1 technologies will be available to the warfighter or stability operations operator with near-zero logistical burden (e.g., no respirator, contamination-free donning and doffing). Further, accidental cross-contamination should be eliminated by the material’s ability to inactivate, sequester, and/or eliminate attachment of agents.
TA1 objectives must be achieved using technologies that prevent agent access to the wearer by blocking, degrading, or otherwise sequestering agent away from the body while also eliminating active agent binding on the material itself post-exposure. Materials that may accomplish this goal might include enzymatic, molecular, nanopore, or other technology and material combinations.
Materials or barriers requiring application of active coatings should be long lasting, durable, and weather resistant. TA1 materials should be lightweight and impose negligible thermal burden or mobility restriction in relation to work rate, duration, or environmental considerations. Garment engineering approaches should consider use in austere and low-infrastructure environments as part of the initial design constraints.
Detailed design goals for TA1 are below
Protect against a broad spectrum (Table 1) of CB threats simultaneously with no impact on mission execution and time on target when compared to operators who do the same tasks without protective materials.
Insignificant logistical or thermal burden during normal military or patient care operations.
Protective materials developed should have evaporative resistance and permeability consistent with current military duty uniforms, such as the Army Combat Uniform (ACU).
Material technologies will have physical performance equivalent to standard-issue military uniforms across all operating conditions to include extreme temperatures, precipitation, humidity, and other environmental scenarios (high dust or other environmental particulates).
Solutions should innovate above standard hydrostatic resistance performance of waterproof fabrics.
Reduce agent attachment to limit exposure risk during donning/doffing.
Durability should exceed the performance criteria of current military duty uniforms (such as the ACU) relative to impact abrasion, seam burst strength, and impact cut resistance.
Rapid don/doff, while also eliminating the risk of contamination to the wearer from incidental exposure to any agent that may have remained on the TA1 components.
System should withstand usage (including repeated donning/doffing) for the entire duration of any deployment.
The system as an ensemble of multiple garments, or as one continuous material should be lightweight, offering protection to the entire head, body, and extremities.
TA2 Neutralize threats at tissue barriers:
This technical area will neutralize agent at one or all of the potential airway, ocular, or skin interfaces, as necessary, to protect against agent exposure. This will supplement TA1’s protective barrier by providing persistent, offsetting, and orthogonal protection against threats that may penetrate the outer layer material or contact the wearer during doffing procedures. Newly adapted BCM technologies must increase CB protection breadth and specificity without sacrificing the protection against the original catalog of CB agents.
BCM will (a) provide simultaneous protection against diverse CB agents; (b) have the ability to add protection against novel threats (as they emerge) to the original catalog of threat protection; (c) be enabled by commensal, synthetic biological and/or nanoparticle-based components; and (d) possess multiple user-controlled safeguards (on/off capability). Proposers should develop innovative approaches to counter CB threats using high-throughput, scalable, molecular and biological production methodologies
The first 24 months of the program are designed as a Design-Test-Refine strategy, organized for teams to develop and evaluate PPB design approaches and enable the teams to iteratively improve their approaches. Teams will have the opportunity to conduct feasibility studies and
tests in collaboration with the IV&V team during the first 18 months. These evaluations are not considered downselection events. Safety testing should demonstrate that preclinical models donned with TA1 and TA2 components (under all states; ‘on’, ‘off’) remain within pre-defined ‘normal physiologies’.