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DOD/CBD SBIR 2012.2 3

SBIR Solicitation 2012.2

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Agency: Department of Defense
Branch: Office for Chemical and Biological Defense
Program/Year: SBIR / 2012
Solicitation Number: 2012.2
Release Date: April 24, 2012
Open Date: May 24, 2012
Close Date: June 27, 2012
CBD12-101: Formulation Development to Enhance Bioavailability and Pharmacokinetic Profile of Protein-based Drugs
Description: OBJECTIVE: Develop novel methods to improve bioavailability and pharmacokinetic profile of protein-based drugs. DESCRIPTION: Protein-based drugs are becoming an increasingly important class of drugs. A great deal of effort is being made to improve their efficacy by improving their bioavailability and increasing their stability within the circulatory system. For example, Human-derived Butyrylcholinesterase (hBuChE) remains to be an effective treatment for pre- and post- exposure to nerve agents. Human BuChE is produced from outdated human plasma and requires large quantities for production. Estimates made in 2008, indicate that the existing capabilities to process blood to be used for bioscavenger production could only make 100,000 doses of bioscavenger per year, far below the estimates needed for protecting the entire military and civilian population. Since the source is limited, it necessitates the need to find an alternate, more reliable source of hBuChE. To date, much of the research has focused on recombinant expression systems. Human BuChE has been successfully made from transgenic goats, transgenic plants, and cultured mammalian cells. Unfortunately several challenges have been identified using these alternate systems. These challenges include: 1.) Reduced bioavailability in the blood 2.) Short half life in the blood stream There are several methods that can be employed to increase the half life of proteins, including pegylation, sialylation etc. It is thought that sialic acids on hBuChE may be responsible for its half-life in the blood stream. To resolve the challenges, formulation development should focus on the following: 1.) Delivering a protein either intramuscularly or subcutaneously and have it be rapidly (within minutes) bioavailable in the blood. 2.) Delivering a protein intramuscularly or subcutaneously that will be enzymatically active and have an extended circulatory presence (multiple days) without inducing an immune response or causing any pathology. 3.) Store an enzyme for long periods of time on the shelf without loss of activity, in a format that is either ready for injection or can rapidly be made ready for injection. The current goal for a maximum dose of a bioscavenger is 1 mg/kg (or roughly 80 mg/adult person), with proteins that are soluble in the 2-20 mg/ml range. It is possible that a dry or semi-solublized formulation could be injected. The key parameter is getting active enzyme into the blood. Development of a technique(s) to improve the bioavailability and stability in the circulatory system of a bioscavenger like BuChE could be applied to any protein-based drug that could be used in Chemical and Biological Defense treatments. PHASE I: Initially, develop a formulation(s) that will improve the bioavailability (within minutes of administration) and pharmacokinetic profile of a protein-based drug, selected by the proposer. The product formulation should extend its shelf life and be readily amenable for intramuscular or subcutaneous injection. Demonstration of the formulation should be evaluated for 2 different proteins in vitro to show that there is no loss of protein activity due to the protein modifications or formulation. PHASE II: Evaluate the pharmacokinetic profile of the formulated protein in plasma in an appropriate animal model to demonstrate that the formulation is superior to existing methodology with regards to protein half-life (greater than 2-fold increase) compared to native protein. In addition, perform toxicologogical and immunological studies in an appropriate animal model to demonstrate that the formulations and modification to the protein does not induce toxicity or an undesired immune response. Demonstration should be conducted on 2 proteins selected by the proposer. PHASE III: Conduct further characterization of the formulated proteins. The proposer should also begin developing a pilot-scale manufacturing process of the formulated protein(s) internally or with a collaborator. An appropriate transition or collaborative partner(s) who will implement this technology in their cGMP manufacturing of protein-based drugs to support the warfighter mission or commercial interests should be identified.
CBD12-102: Advanced Purification Technology for the Manufacture of Vaccines, Biologic Drugs, and Enzymes
Description: OBJECTIVE: Develop novel, non-synthetic-resin-based protein purification technologies that enables the low-cost production of kilogram quantities of proteins for chemical and biological defense applications. DESCRIPTION: Recent investments by the DoD have been made in areas to increase the agility of the government to respond to a future pandemic or chemical/biological threat in development of appropriate countermeasures. This includes novel manufacturing platforms that can rapidly respond to expression of a given protein, given an unknown target sequence, and also rapidly scale the production of protein to meet national needs. The utility of these manufacturing platforms however can extend beyond protein based vaccines and therapeutics and have proven potential in manufacturing industrial proteins at scale for other DoD applications such as sensors and remediation based technologies. The protein manufacturing process generally consists of two distinct phases: 1) protein synthesis and 2) recovery and purification of the protein of interest from the matrix of the source organism. Although efforts are ongoing to develop alternative expression platforms (recombinant protein manufacturing hosts), often the low cost production of the desired protein ("Upstream"production) does not reduce the"Downstream"costs of manufacturing. The downstream processing costs typically represent the majority of the expense associated with manufacturing recombinant proteins and can be as high as 60 to 80% of the total manufacturing costs for biologic drugs. These costs can often be prohibitory in development and deployment of a viable countermeasure technology. Current protein manufacturing technology relies primarily on chromatographic resins and other methods which have been used for decades. Ion exchange chromatography, size exclusion chromatography, hydrophobic interaction chromatography, affinity chromatography, and other similar methods are well understood process steps that are relied upon as workhorses in protein therapeutic manufacturing. While these methods are functionally robust, they tend to be expensive to execute with high material and labor costs and limit the amount of product that can be produced from a single production batch. In addition, the purification materials (resins, etc) themselves can be limited in availability for large scale use without long lead times. Recent advances have been made in exploring alternative methods, such as aqueous phase separation or self-cleaving affinity tags. Advanced downstream processing technologies that are widely applicable to recovery and purification of a number of protein classes and applications are needed. Preference will be given to biotechnology-based strategies which can supplant traditional chromatographic methods and their associated high labor and material costs. The technology should be applicable to recover and purify proteins from various production hosts and provide significant cost reductions of at least two-fold compared to conventional methods. The technology should also demonstrate ability to scale on demand for use in rapid response manufacturing. The technology must provide purified protein preparations with technical specifications as good as or better than conventional technologies across a range of targets. PHASE I: Develop a non-synthetic-resin-based protein purification technology capable of recovering and purifying a range of protein products in a manner which meets the technical requirements for the specific proteins-of-interest. Express and purify two (2) different proteins of interest to the DoD at pilot scale using the novel technology and demonstrate purity is comparable or better to that of the same proteins expressed in same expression platform but purified with traditional chromatographic methods. PHASE II: Demonstrate a cost-effective production technology (2-fold less compared to conventional technologies) for selected protein product targets relevant to the DoD. Demonstrate that the technical efficiency of recovery, protein product quality and cost efficiency of the process are suitable for the protein product. Demonstrate the utility of this process at large scale. PHASE III: The development of a novel downstream processing technology should complement novel large scale biological expression platform technologies being developed by the DoD to rapidly express proteins of interest for medical countermeasures and industrial technologies. The proposer should identify appropriate transition or collaborative partners who will use this technology in their manufacturing process in expression of proteins that support the warfighter mission. The economic purification of these proteins may also be beneficial in the commercial sector and for Homeland Security.
CBD12-103: Design Automation Software for DNA-Based Architectures
Description: OBJECTIVE: Develop and demonstrate a DNA design automation software package that allows for the specification of large and complex DNA-based architectures. Develop methods to define and manipulate charge and hydrophilicity at the nanoscale. DESCRIPTION: The folding of single- and double-stranded DNA is a chemically well-understood and controllable process. DNA is generally associated with the storage of genetic information. However, in many ways, it is also an ideal building material. DNA"s sequence dictates its shape and structure. Recently, progress has facilitated inexpensive and easy manufacturing of DNA strands with custom sequences. Much of the science of DNA origami is centered on producing better design software. The ability to produce better design software is a critical component of the controlled design and production of large complex structures using DNA origami. There is a need in the chemical/biological defense community to develop new and novel bio-structures. In particular, DNA self-assembly methods have become useful in the mimicry of biological systems such as antibodies and vaccines. In order to mimic biological systems, a DNA origami structure must possess a shape that mimics the antibody or vaccine structure. It needs to also mimic the charge distribution and hydrophobic/hydrophilic nature of a bio-structure at the nanoscale. To extend DNA origami techniques to bio-molecular applications, the development of simulation tools for defining electrostatic and hydrophilic properties of structure at the nanoscale are needed. In the DNA origami approach, a large DNA structure, such as a plasmid or virus, is tethered together using short strands of DNA that are called"staples". Since every base of the staple DNA strands can be modified, the surface charge distribution on the surface of a DNA origami can be controlled. Likewise hydrophobic and hydrophilic regions can be precisely determined and manipulated. However, current design software packages do not support these needs. Improved design software is needed to support the requirements of the chemical/biological defense community. Recent advances in the development of evolutionary search algorithms have provided the ability to perform optimizations over sequence design spaces previously thought to be intractable. However, a comprehensive development tool for developing very complex DNA-based nanostructures and architectures still does not exist. An ideal development tool would be able to determine optimal sequence sets according to first principle constraints that are imposed by topology, molecular thermodynamics and self-assembly kinetics. The system would also be able to accommodate designs with up to 30,000 bases and arbitrarily complex pseudo-knots. An ideal system would also address the problem of localized target melting temperatures and would address kinetics as well as thermodynamic issues. A necessary component of a new design tool will be a graphical user interface (GUI) which would allow specification of nanostructure designs, including strand position and topology, designation of the location of non-DNA species in the design and the designation of fixed bases versus variable bases. PHASE I: Produce a detailed requirements document for a design automation tool that addresses the needs of the chemical and biological defense community in the area of bio-mimicry using DNA origami techniques. In particular, the ability to define charge distribution as well as hydrophilicity and hydrophobicity at the nanoscale should be addressed. The DNA-based design should also address the computational resources that will be required for these applications. Design software that can function in a distributed computing environment is preferred. A description of the core thermodynamics and sequence optimization algorithms should be provided. A distributed, design tool architecture should be proposed that satisfies the usability and computational complexity challenges of the envisioned application. A plan for producing DNA staples with necessary functionality should be addressed. Phase I efforts that also include a corresponding proof-of-concept software demonstration are strongly preferred. PHASE II: Develop a prototype software application that allows complex nanostructure designs to be specified and automatically populated with optimized sequences. Develop design software that allows for the specification of charge and hydrophilic/hydrophobic structures at the nanoscale. The research and development work should include experimental verification that the resultant sequence sets self-assemble into the targeted designs with high fidelity and yield. The relevance to defense and security applications should be demonstrated through simulation of a bio-molecular structure response. In particular, the problem of molecular recognition should be addressed. Non-covalent bonding to a biomolecule of interest should be modeled and demonstrated. For demonstration purposes, Streptavidin should be used as a target molecule. PHASE III: Further research and development during Phase III efforts will be directed towards refining a final design, incorporating design modifications based on results from tests conducted during Phase II, and improving the software to meet Chemical and Biological Defense Programs goals and end-user requirements. PHASE III DUAL USE APPLICATIONS: The new design software will have broad impact across several avenues of defense applications. Once an effective prototype software system is achieved, the system will be amenable to the design of numerous architectures for biological sensing and characterization. Specifically, the software will be a key enabler of sensors having relevance to scientific studies of biological materials, to the detection and identification of biological threats, to medical diagnostics and therapeutics of biological induced diseases, and to the monitoring of commercial consumables for biological contamination.
CBD12-104: Detection of Liquid Contaminants on Surfaces Using Hyperspectral Imaging
Description: OBJECTIVE: Develop a hyperspectal imaging standoff sensor for detecting liquid contaminants on surfaces using passive infrared spectroscopy based on cold-sky reflectance. DESCRIPTION: Surface contamination by CB agents presents a serious threat both to the civilian and military sectors and an adequate defense against these weapons will require rapid detection and identification of both known and unknown agents. Recent measurements in the scientific literature suggest that passive long wave infrared sensors are capable of detecting liquids on the ground by utilizing cold sky reflectance. Cold-sky reflection drives the physics of passive detection of liquids on surfaces. The sky is radiometrically very cold, emitting far fewer infrared photons than objects on the ground. Due to cold sky reflectance, there is an apparent enhanced emission of the resonance bands of the liquid on the ground, which is at ambient temperature. A number of open literature publications have appeared that demonstrate the ability of this technology to detect surface contamination at relevant concentration for the needs of the chemical/biological defense community. A passive infrared approach offers advantages in terms of wide area detection capabilities. The Joint Chemical Surface Detector (JCSD) program has the goal of detecting liquid and solid chemicals on the ground using noncontact technologies. The system is required to rapidly interrogate the ground to provide wide area standoff detection of chemical warfare agents (CWA) and Toxic Industrial Chemicals (TICs) in real-time. This system has shown the potential to significantly increase the operational speed of the Stryker NBCRV and future reconnaissance vehicles by enabling rapid surface agent detection and identification. Currently the JCSD program utilizes a laser Raman based sensor. The laser system places a small laser spot on the ground. The detection of a chemical contaminant is determined by inelastic scatter from the liquid or solid contaminant. In situations where the contamination is in the form of droplets, this requires that the laser intercept a droplet of contaminated liquid. Also the use of a laser-based detection system raised issues such as eye-safety hazards and high power consumption. The detection of relevant contaminants on surfaces is challenging because they typically exist in the form of sparse, optically thick droplets with a median mass diameter (MMD) of 0.5 mm or less. Contamination can be as low as 1 droplet per square centimeter and still exceed the objective detection level of 0.5 gram/m^2 that are set for the JSCD. The current laser-based JSCD can easily pass over a contaminated surface without detection due to low probability of intercept of the small laser beam with a small droplet. A false negative can place personnel at risk. A hyperspectral imaging (HSI) approach would significantly increase the probability of intercept with a contaminated droplet on the ground. In the HSI approach, a large area is monitored. A droplet appearing anywhere within the view of the HSI instrument is instantly detected. The false negative rate would be significantly decreased, providing better protection for personnel and equipment. On-the-move detection of this sparse droplet field is further complicated by the need to collect the signal at short acquisition times and high frame rates in order to avoid spatial and spectral blurring due to vehicle motion as well as increase the probability of particle intercept within the detector"s field of view. On-the-move operation requires vehicle speeds as fast as 45 miles per hour. Operating a hyperspectral imager at the very high data rates imposed by this effort will require advances in high speed signal processing and will likely require new algorithm development. It is envisioned that the initial HSI system would use approximately a 1 meter standoff detection distance looking a 30 to 60 degree angle from the vertical and would be positioned in front of the moving vehicle. It is desirable to extend this technique to longer standoff ranges. Using passive standoff techniques, it should be possible to extend the standoff range to 100 meters or more. Operating at longer standoff distances should be straightforward. Passive detection utilizes cold-sky reflection. The cold-sky reflection provides a constant source term at all distances. However, issues related to slant angle and field-of-view will need to be determined. Larger collection optics may be required at longer distances. PHASE I: Conduct a feasibility study of detecting liquid contaminants on the ground using a passive long wave infrared hyperspectral imaging spectroradiometer operating in the 8 to 12 m (micron) region of the electromagnetic spectrum. Perform spectral measurements of a contaminant deposited on concrete, painted metal, grass, and sand surfaces in order to validate the sensor and algorithm models. For this study, a silicone based lubricant should be used. Examine droplets of mission-relevant sizes (~500 m, micron) on relevant surfaces. Examine the hyperspectral images of surfaces with contaminant present and absent using unpolarized and S-polarized infrared radiation. Develop a system model and the conceptual design of a fast hyperspectral imaging detection system for on-the-move detection. The system should operate in the 8-12 micron region of the spectral region and have necessary spectral resolution to detect chemical agents. The system should assume speeds of operation up to 45 mph with a standoff distance of 1-2 meters and a slant angle of 30 to 60 degrees from the vertical. The system should be able to detect 0.5 mm droplets of contamination on a surface running at these velocities and still provide coverage of a reasonable area in front of the reconnaissance vehicle. Examine issues related to slant-angle, field-of-view, and collection optics. Examine methods for extending the standoff range to larger distances. PHASE II: Develop a model to describe how well the proposed system will perform. After reviewing the results of the model with the DoD Technical Point of Contact, build a hyperspectral imaging sensor operating in the 8-12 micron region of the spectral region that can operate from a moving vehicle traveling at 45 mph with a standoff distance of 1-2 meters and a slant angle of 30 to 60 degrees from the vertical. The system should have sufficient spectral resolution to detect chemical agents. The system should be able to detect a 0.5 mm droplet of contamination on a surface running at 45 mph and still provide coverage of a reasonable area in front of the reconnaissance vehicle. Develop necessary data acquisition system to provide real-time detection of chemical agents and stimulants. Develop all necessary detection algorithms for real time detection. Demonstrate detection of liquid contaminants on surfaces using a simulant such as a small amount of a silicone oil. Examine the utility of using the sensor at longer standoff ranges. Examine methods for extending the standoff range to 100 meters or more. Issues related to slant-angle, field-of-view, and collection optics should be examined. PHASE III: Further research and development during Phase III efforts will be directed towards refining a final deployable design, incorporating design modifications based on results from tests conducted during Phase II, and improving engineering/form-factors, equipment hardening, and manufacturability designs to meet the operational requirements of the Joint Chemical and Biological Defense Program, U.S. Army CONOPS and end-user requirements. PHASE III DUAL USE APPLICATIONS: There are many environmental applications for a sensitive standoff chemical detector/identifier. A rugged, sensitive, and flexible standoff chemical detector will benefit the manufacturing community by providing very finely tuned monitoring of chemical processes. Also, first responders such as Civil Support Teams (CST) and Fire Departments have a critical need for a rugged, versatile, and rugged sensor that can be transported to the field to test for possible contamination by chemical warfare agents.
CBD12-105: Oxygen Storage Technology for Closed-Circuit Self-Contained Breathing Apparatus
Description: OBJECTIVE: To develop high-capacity, low-pressure oxygen storage technology for the development of lower maintenance and lighter weight closed-circuit self-contained breathing apparatus with reduced logistical burden. DESCRIPTION: A Self-Contained Breathing Apparatus (SCBA) is a type of respiratory protection device that provides breathing gas from a source independent of the surrounding atmosphere. A closed-circuit SCBA or"rebreather"re-circulates the breathing air after the carbon dioxide has been removed and the oxygen content restored by either a compressed or liquid oxygen source or an oxygen generating solid. The most common type of non-escape rebreather used in the workplace employ a compressed oxygen cylinder under high pressure to replenish the depleted oxygen in the re-circulated breathing air. The main advantage of a closed-circuit verse an open-circuit SCBA, whereby the breathing gas from a compressed air cylinder is exhaled to the outside, is the extended wear time capable of these devices. Rebreathers have a service life of up to 4 hours whereas open-circuit SCBAs have a maximum service life of only 45 minutes to one hour. However, to achieve their long service life the oxygen cylinder in a rebreather device must be filled to a high pressure (~3000 psi). Special equipment and procedures are required to safely handle and refill these specially designed high-pressure cylinders. This substantially increases the cost and logistical burden of using these devices. Novel technology is needed to overcome the shortcomings associated with high-pressure oxygen storage. Innovative oxygen storage solutions are sought that reduce the weight, maintenance, and overall logistic burden associated with high-pressure oxygen cylinders while providing comparable performance in rebreather applications. Potential solutions may include novel physisorptive media (e.g., zeolites and carbon nanotubes), low-power oxygen concentrating technology, or hybrid systems. The goal is to develop a lower maintenance, lower profile, and lighter weight closed-circuit SCBA for unique military operations. Such operations may include prolonged entry into immediately dangerous to life and health (IDLH) atmospheres or unknown CBRN environments. PHASE I: Develop high-capacity, low-pressure, oxygen storage technology that offers significant improvements in the logistical burden associated with the refilling and handling of high-pressure cylinders. Demonstrate feasibility of proposed enabling technology solution(s) through computer modeling and use of existing empirical data where available. Identify key performance parameters and test criteria relevant to closed-circuit SCBA applications. Establish test set up and procedures to assess and validate proposed approach. Fabricate physical"breadboard"model and conduct bench top testing to characterize the performance of the proposed solution(s) to include but not limited to the following, where applicable to the proposed technology: adsorption capacity, desorption rate, adsorption enthalpy (thermodynamic properties), power requirements, production by-products, and efficiency under relevant temperature/humidity conditions. PHASE II: Refine and optimize Phase I breadboard model to improve oxygen storage capacity and performance. Perform follow-on bench top evaluations to verify improvements made to the basic enabling technology. Modify test setup and improve test procedures as required. Develop functional scalable prototype by incorporating enabling technology into a suitable test bed (e.g., oxygen storage platform or container). Characterize test bed performance under an operational relevant range of external environmental (temperature/humidity) conditions and in-mask heat/humidity loads. The evaluations should include characterizing the breathing air quality, release of any by-products, exothermic reactions, and other factors relevant to the technology. Based on results obtained, implement necessary refinements to the scalable test bed model. PHASE III: Fully integrate solution into a full-scale, fully-functional prototype containment unit comparable to the size and weight of a typical rebreather oxygen cylinder. Demonstrate ability of the technology to be incorporated into a fully-functional closed-circuit SCBA through modification of an existing off-the-shelf system. Expand applications to other commercial markets to include industrial and homeland defense closed-circuit SCBAs. PHASE III DUAL USE APPLICATIONS: Potential alternative applications include firefighting, industrial, mine rescue, and escape SCBAs. Other possible applications include gas purification, gas separation, and underwater breathing devices (SCUBA).
CBD12-106: Carbon Dioxide and Water Removal Technology for Closed-Circuit Self-Contained Breathing Apparatus
Description: OBJECTIVE: To develop high-capacity, low-pressure carbon dioxide removal technology for the development of lower maintenance and lighter weight closed-circuit self-contained breathing apparatus with reduced logistical burden. DESCRIPTION: A Self-Contained Breathing Apparatus (SCBA) is a type of respiratory protection device that provides breathing gas from a source independent of the surrounding atmosphere. A closed-circuit SCBA or"rebreather"re-circulates the breathing air after the carbon dioxide has been removed and the oxygen content restored by either a compressed or liquid oxygen source or an oxygen generating solid. The most common type of non-escape rebreather used in the workplace employs a compressed oxygen cylinder under high pressure to replenish the depleted oxygen in the re-circulated breathing air. Carbon dioxide is typically removed using an absorbent material such as soda lime. The primary advantage of a closed-circuit verse an open-circuit SCBA, whereby the breathing gas from a compressed air cylinder is exhaled to the outside environment, is the extended wear time capable of these devices. Rebreathers have a service life of up to 4 hours whereas open-circuit SCBAs have a maximum service life of only 45 minutes to one hour. The current carbon dioxide removal process uses an exothermic reaction and does not remove the water produced by the exhaled air. The generated heat is typically removed using ice or re-freezable cooler packs1,2 incorporated into the re-breather system, increasing the weight and logistics. Additionally, the absorbent material cannot be regenerated and must be replaced when expended. Novel technology is needed to overcome the shortcomings associated with carbon dioxide and water removal. Innovative carbon dioxide and water removal solutions are sought that reduce the weight/size, maintenance, and overall logistic burden associated with currently employed chemical absorbent materials such as lithium hydroxide while providing comparable performance in rebreather applications. Potential solutions may include novel physisorptive media (e.g., zeolites, carbon nanotubes), chemical reactions, or hybrid systems. Efficiency improvements that reduce exothermic heat production over current technologies are desirable. Solutions that also generate oxygen, such as with a KO2 process,3 are acceptable but not required. Technologies that are non-hazardous in use and disposal are desirable. The goal is to develop a lower maintenance, lower profile, and lighter weight closed-circuit SCBA for unique military operations that does not have the heat, size, and weight burden seen in current rebreather systems.4 Such operations may include prolonged entry into immediately dangerous to life and health (IDLH) atmospheres or unknown CBRN environments. PHASE I: Develop high-capacity, low-pressure carbon dioxide removal technology that offers significant improvements in the logistical burden associated with currently used absorbent materials and ice packs. Demonstrate feasibility of proposed enabling technology solution(s) through computer modeling and use of existing empirical data where available. Identify key performance parameters and test criteria relevant to closed-circuit SCBA applications. Establish test set-up and procedures to assess and validate proposed approach. Fabricate physical"breadboard"model and conduct bench top testing to characterize the performance of the proposed solution(s) to validate improvements to the limitations of current rebreather materials to include but not limited to the following where applicable to the proposed innovative technology: adsorption capacity, desorption rate, adsorption enthalpy (thermodynamic properties), power requirements, production by-products, efficiency under relevant temperature/humidity conditions, and size/weight reductions. PHASE II: Refine and optimize Phase I breadboard model to improve carbon dioxide removal capacity and performance. Perform follow-on bench top evaluations to verify improvements made to the basic enabling technology. Modify test setup and improve test procedures as required. Develop functional scalable prototype by incorporating enabling technology into a suitable test bed (e.g., carbon dioxide storage platform or container). Characterize test bed performance under an operational relevant range of external environmental (temperature/humidity) conditions and in-mask heat/humidity loads. The evaluations should include characterizing the breathing air quality, release of any by-products, exothermic reactions, and other factors relevant to the technology. Based on results obtained, implement necessary refinements to the scalable test bed model. PHASE III: Fully integrate solution into a full-scale, fully-functional prototype containment unit comparable to the size and weight of a typical re-breather carbon dioxide absorbent and cooling mechanism. Demonstrate ability of the technology to be incorporated into a fully-functional closed-circuit SCBA through modification, where feasible and appropriate, of an existing off-the-shelf system. Expand applications to other commercial markets to include industrial and homeland defense closed-circuit SCBAs. PHASE III DUAL USE APPLICATIONS: Potential alternative applications include firefighting, industrial, mine rescue, and escape SCBAs. Other possible applications include gas purification, gas separation, and underwater breathing devices (SCUBA) for recreational divers.
CBD12-107: Continuous Ionization System for Electrostatic Collection of Bioaerosols in Building Protection Applications
Description: OBJECTIVE: Develop a system capable of continuous ionization of airborne bioaerosols in the 0.5-5 m size range that does not generate ozone. The system should be designed for use in electrostatic removal of bioaerosols in HVAC environments at reduced operational costs compared to HEPA filtration. DESCRIPTION: Continually operating, or"always on,"removal of airborne particulates provides not only day-to-day treatment of air in building environments but also provides the most rapid response in the event of a biological contamination event, such as an aerosolized anthrax attack. These systems require no sensors or activation delays since they are already up and running. Systems currently used for high removal efficiency of particulate contaminants are limited to fabric filters and electrostatic precipitation. Filters such as HEPA are effective at removing particles, but induce a large pressure drop (1-6"W.G. depending on loading) that is expensive from an energy standpoint. While electrostatic precipitators are widely used in particulate removal in flue gas streams, typical ionization methods utilize a corona discharge that may generate significant (>10 ppm) levels of ozone which is undesirable in an indoor environment. Standard air filtration relies on impaction and interception of particles on filter fibers. Prolonged use requires cleaning or replacement of filter media. To achieve high particle removal efficiencies, more tightly woven filters are utilized, increasing energy costs associated with the pressure drop across the filter. Additionally, filters contaminated with biological material are hazardous and must be properly disposed of to avoid spread of contaminants. Ionization-based filtration processes charge particulate matter in the air stream which is subsequently collected by electrostatic precipitation, eliminating the pressure drop associated with fabric filters. Ionization of the airborne particulates is traditionally obtained by corona discharge. However, work funded under a previous SBIR project has demonstrated that an effective ionization region can be established using an electrospray wick array. As with industrial-type electrostatic precipitation systems, it is possible to remove contaminants without the need to directly contact the collection surface, thus eliminating the difficulties associated with disposal of fabric filters. Electrospray ionization has been used for laboratory chemical analysis and has recently been proposed for incorporation into low-pressure drop air filtration units demonstrating a potential reduction in O&M costs while providing particle removal rates similar HEPA filtration. One significant benefit of electrospray ionization is that ozone is not formed as a byproduct of the process. Rather than direct ionization of particles by an applied voltage difference, electrospray induced ionization of airborne particulates is achieved by charge transfer to the particle from a water based aerosol. Implementation of electrospray into"always on"air filtration applications is currently limited by the lack of reliable, continuous-feed fluid delivery mechanisms for ionization. Recently, bipolar ionization (BPI) has been demonstrated as an effective method for charging of indoor aerosols, inducing agglomeration and settling of particles, as well as destruction of harmful VOCs. Additionally, BPI has been used as a charging mechanism for a newly designed aerosol time-of-flight mass spectrometer coupled with a differential mobility analyzer and charged plates. BPI can generate high levels of negative and positive ions in an indoor environment without producing ozone and has potential for use in electrostatic precipitation applications. This topic seeks the development of a novel system for bioaerosol ionization to be used in an electrostatic collection system for building protection applications. PHASE I: Conduct research on ionization systems that provide uniform and continual delivery of the ions across the entire volume of influent air. The system should be designed for autonomous operation requiring minimal maintenance or user operation (service less than once per month). Additionally, power consumption should be targeted to achieve less than 1.0 watts per cubic feet (35.3 W/m3) of treated air, to align with Department of Defense goals to reduce energy costs. The system should be capable of adapting to treatment of a high concentration spike of bioaerosols that would occur during a biological attack. By the end of Phase I, continual operation of the proposed ionization system should be demonstrated for periods of at least one week without losing effective ionization capabilities or having to replace consumables. The system should be capable of operating for at least two weeks without need for maintenance or replenishing consumables. It should be able to ionize 2,000 particles per cm3 at 50 CFM (1.42 m3/min) to a level adequate for removal of 99.97% of 0.3-1.5 um (micron) diameter particles in a 20 kV downstream collection region with no measurable ozone generation and minimal temperature increase (<5 degrees C). Particular attention should be paid to ionization of biological particles of this size range using surrogate spores. The specific surrogate to be employed must be proposed and approved by the DoD Technical Point of Contact. It is not necessary to demonstrate the collection region in Phase I. PHASE II: Design and test a filtration system building upon the ionization concepts developed in Phase I. Technology for electrostatic collection of the charged particles will be explored and tested in combination with the most promising ionization mechanism. Candidate integrated ionization and collection systems should be refined with regards to energy consumption, particle removal efficiencies, ease of operation, and effectiveness in the presence of biological materials contamination in addition to normal particle loadings. Extended duration tests should be accomplished over a variety of temperature and humidity levels. The culmination of Phase II should result in a validated, pilot-scale prototype capable of operation at 2,000 CFM (56.6 m3/min) and a plan for full size scale-up. Effective ionization and collection of surrogate bioaerosols with particle removal efficiencies greater than 99.9% of the 0.3-1.5 m (micron) size particles should be demonstrated. Additionally, energy consumption in the final system should be favorable when compared to HEPA filtration. PHASE III: Production of a full size filtration system (>20,000 CFM [>566 m3/min]) for demonstration at an DoD installation or other relevant facility. Product performance should be verified to meet the metrics targeted for the bench scale system. At this stage, attention should be paid to parameters such as operational noise, product footprint, and material costs and modifications made as necessary to increase commercialization and manufacturing potential. PHASE III DUAL USE APPLICATIONS: Electrostatic air filtration technology has potential markets both within and outside of the government for buildings in which there is an elevated threat of chemical and biological contamination. In addition, the technology has the potential to be used in hospitals, schools, and other buildings where high levels of indoor air purification are desired as an alternative to HEPA filtration.
CBD12-108: Rapid Sample Transport in Austere Environments
Description: OBJECTIVE: To develop advanced, innovative approaches for rapid sample preservation and transport in austere environments. Topic objectives include innovative technologies to enable a low-cost capability to preserve and exfiltrate small medical and environmental biological samples from austere locations and precisely deliver the sample to a pre-determined recovery area. Austere locations are defined as remote and typically inaccessible locations. This capability will be used to exfiltrate medical or environmental samples from an inaccessible area, perhaps with Chemical and/or Biological issues, to enable rapid receipt of physical samples at a laboratory analysis facility. DESCRIPTION: In austere and inaccessible environments, exfiltration of critical medical, chemical and/or biological samples can be difficult. Lack of maintained infrastructure, inaccessible or remote locations and other factors can limit the ability to transport samples from the area of interest to a location with suitable laboratory facilities. The Chemical, Biological, Radiological, and Nuclear (CBRN) sample, which will weigh up to approximately two pounds, will need to be packaged to preserve the sample integrity, and then transported distances ranging from 50 to 1000+ miles to a point within approximately commercial Global Positioning System (GPS) levels of precision. Innovative solutions may choose to focus on part or all of this time/distance/weight performance tradespace -- for instance, lighter packages that travel shorter distances, or heavier packages that travel longer distances. At the end of the transport, the sample should be able accurately delivered (commercial GPS-levels of precision) to a pre-determined and/or in-route updated location for recovery by ship or by a ground recovery team. Transport could take as little as 1 hour or as much as 4 days from the time the sample is packaged. The system needs to provide near real-time tracking of the sample from initiation to the final delivery location. Because this system will be used in remote locations and austere environments, a self-contained set-up that can be operated by non-expert personnel after minimal training is required. For more than 50 years, researchers have defaulted to freezing biological samples at -20degreesC or -80degreesC as a means of preservation and storage. It is critical to maintain the integrity and quality of nucleic acids for use in downstream analysis. Using current standards for sample preservation via freezing and shipping with dry ice, proposed approaches would be constrained by a requirement to include in an insulated container approx 7lbs of dry ice for every 24 hours of transport time. Dry ice mass should be calculated to ensure complete sublimation will not occur prior to the package arriving at the destination site. Sublimation is the transition from solid directly to gas since it does not transition from solid to liquid to gas. Storing and preserving the quality of nucleic acids at ambient room temperature would represent a paradigm shift with significant savings in cost, environmental impact and ensured sample integrity. Innovative approaches to room temperature sample preservation may be included in the proposed approaches as a means to extend the performance envelop since this may significantly reduce the size/weight limits and the logistics for obtaining dry ice in austere environments. The proposed approach should have the following properties: 1) A basic design architecture and a crosswalk between the proposed low-cost design approach and key performance metrics to include end-to-end timeline analysis as a function of payload weight and distance. 2) A basic operational construct matched to the innovations proposed, including proposed or assumed method for sample preservation, transport, precision delivery, and near real-time tracking of the sample from initiation to the final delivery location. 3) A proposed prototype approach that would demonstrate the capability. Identification of any specific Government Furnished Equipment (GFE) associated with future capability demonstration phases to include possible use of Government test sites. PHASE I: Determine the feasibility of a low-cost rapid sample transport system for use in austere environments. Develop the initial design architecture and a proposed test event for proof-of-concept. Identify key system dependencies and assess global availability of capabilities, like the use of GPS, SATCOM, weather balloons, air corridor restrictions, etc. Develop an initial planning tool to support operational capabilities and limitations for the proposed innovation. For instance, if the proposed transport mechanism uses a low-cost balloon, then given a specific sample collection location, the tool would determine viable destination sites as a function of weather/wind limited by system range, mass, and sample viability timeline restrictions. Down-select to the most promising technologies for further testing in a realistic environment in Phase II. PHASE II: Design a prototype system that best integrates the proposed components into an optimized system, and demonstrate at least two sample transport events using two different ranges and payload weights. Update the system planning tool to incorporate initial demonstration results. PHASE III: Develop and perform two overseas field-demonstration for recovery at land and sea locations. Analyze cost-performance trade-offs for low-cost disposable and options for creation of version sets that are releasable and usable by foreign national partners while abiding by International Traffic in Arms Regulations (ITAR) restriction limitations. PHASE III DUAL USE APPLICATIONS: Enhancements to sample preservation and transportation have wide applications in worldwide medical surveillance, detection and response markets. Other Potential DoD Uses for Technology Innovations: this capability could also be used for the placement of small sensors or unmanned ground systems (UGS) into denied areas. In this situation, the system would be launched from friendly territory, such as a ground location or a boat, and would transport the sensor or UGS into a denied area. Once in the denied area, the system would deliver the sensor or UGS to within ten (10) meters of a desired ground or water location. The system could also be used to measure and transmit atmospheric data to provide real-time weather information via a communications link. Because one operational low-cost construct may be via the use of an altitude adjustable balloon that drifts with the wind and deploys a small guided airdrop system for final delivery, then this system could also be used to return the expensive electronic components of sondes and artillery balloons or commercial weather launch systems to allow for multiple re-uses and to collect weather during assent and descent.