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All sourcesNASA NTRSDOE OSTI
NASA NTRS2014

Stability Analysis of ISS Medications

It is known that medications degrade over time, and that extreme storage conditions will hasten their degradation. The temperature and humidity conditions of the ISS have been shown to be within the ideal ranges for medication storage, but the effects of other environmental factors, like elevated exposure to radiation, have not yet been evaluated. Current operational procedures ensure that ISS medications are re-stocked before expiration, but this may not be possible on long duration exploration missions. For this reason, medications that have experienced long duration storage on the ISS were returned to JSC for analysis to determine any unusual effects of aging in the low- Earth orbit environment. METHODS Medications were obtained by the JSC Pharmacy from commercial distributors and were re-packaged by JSC pharmacists to conserve up mass and volume. All medication doses were part of the ISS crew medical kit and were transported to the International Space Station (ISS) via NASA's Shuttle Transportation System (Space Shuttle). After 568 days of storage, the medications were removed from the supply chain and returned to Earth on a Dragon (SpaceX) capsule. Upon return to Earth, medications were transferred to temperature and humidity controlled environmental chambers until analysis. Nine medications were chosen on the basis of their availability for study. The medications included several of the most heavily used by US crewmembers: 2 sleep aids, 2 antihistamines/decongestants, 3 pain relievers, an antidiarrheal and an alertness medication. Each medication was available at a single time point; analysis of the same medication at multiple time points was not possible. Because the samples examined in this study were obtained opportunistically from medical supplies, there were no control samples available (i.e. samples aged for a similar period of time on the ground); a significant limitation of this study. Medications were analyzed using the HPLC/MS methods described in the United States Pharmacopeia (USP) to measure the amount of intact active ingredient, identify degradation products and measure their amounts. Some analyses were conducted by an independent analytical laboratory, but certain (Schedule) medications could not be shipped to their facility and were analyzed at JSC. RESULTS Nine medications were analyzed with respect to active pharmaceutical ingredient (API) and degradant amounts. Results were compared to the USP requirements for API and degradants/impurities content for every FDA-approved medication. One medication met USP requirements at 5 months after its expiration date. Four of the nine (44% of those tested) medications tested met USP requirements up to 8 months post-expiration. Another 3 medications (33% of those tested) met USP guidelines 2-3 months before expiration. One medication, a compound classed by the FDA as a dietary supplement and sometimes used as a sleep aid, failed to meet USP requirements at 11 months post-expiration. CONCLUSION Analysis of each medication at a single time point provides limited information on the stability of a medication stored in particular conditions; it is not possible to predict how long a medication may be safe and effective from these data. Notwithstanding, five of the nine medications tested (56%) met USP requirements for API and degradants/impurities at least 5 months past expiration dates. The single compound that failed to meet USP requirements is not regulated as strictly as prescription medications are during manufacture; it is unknown if this medication would have met the requirements prior to flight. Notably, it was the furthest beyond its expiration date. Only more comprehensive analysis of flight-aged samples compared to appropriate ground controls will permit determination of spaceflight effects on medication stability.

Wotring, V. E.↗
NASA NTRS2014

NASA, We Have a Challenge and It's Food Packaging

Current Packaging: Freeze Dried Foods Packaging  The thermoformed base is fabricated from Combitherm PAXX230 [a coextrusion of nylon/medium-density polyethylene (MDPE)/nylon/ethylene-vinyl alcohol (EVOH)/nylon/MDPE/linear low-density polyethylene (LLDPE)].  The lid is fabricated from Combitherm PAXX115 (a coextrusion of nylon/EVOH/nylon/LF adhesive/HV polyethylene/LLDPE)  Natural form (Bite size) foods  The bite-size food package is fabricated from Combitherm PAXX115, a coextrusion of nylon/EVOH/nylon/LF adhesive/HV polyethylene/LLDPE.  Overwrap  Packages are wrapped in a white pouch,.003-mm thick, fabricated from a laminate of polyester/polyethylene/aluminum foil/Surlyn®. This overwrap is removed before the food is prepared and heated. Requirements  High barrier packaging - low oxygen and water vapor transmission rates  No aluminum layer  Mass - <145 grams per m2  Flexible  Puncture resistant  Approved for food use  Amenable to sterilization  Able to be heat sealed  Preferred (not required)  Transparent  Retortable, microwavable, high pressure use. Small Business Innovative Research Program - 7 years  8 Phase I contracts  4 Phase II contracts  Two workshops to bring together food packaging experts  Three internal research tasks  Public Outreach - average of 3 presentations/yr. for 8 years describing NASA's challenges  Department of Defense Collaboration - Combat Feeding Program No significant improvement in food packaging capabilities after these efforts. It was unlikely that a food packaging solution could be found within the food science community  There was a need to go outside to other industries such as pharmaceutical or electrical  Although a positive result was preferred, a negative result would also be useful  Two Innovation Techniques were used as a comparison  InnoCentive - Theoretical Challenge to identify new technologies  Yet2.com - A matchmaker between NASA and commercial packaging manufacturers

Perchonok, Michele↗
NASA NTRS2014

Efficacy of Antimicrobials on Bacteria Cultured in a Spaceflight Analogue

As humans travel in space, they will interact with microbial flora from themselves, other crewmembers, their food, and the environment. While evaluations of microbial ecology aboard the Mir and ISS suggest a predominance of common environmental flora, the presence of (and potential for) infectious agents has been well documented. Likewise, pathogens have been detected during preflight monitoring of spaceflight food, resulting in the disqualification of that production lot from flight. These environmental and food organisms range from the obligate pathogen, Salmonella enterica serovar Typhimurium (S. Typhimurium), which has been responsible for disqualification and removal of food destined for ISS and has previously been reported from Shuttle crew refuse, to the opportunistic pathogen Staphylococcus aureus, isolated numerous times from ISS habitable compartments and the crew. Infectious disease events have affected spaceflight missions, including an upper respiratory infection that delayed the launch of STS-36 and an incapacitating Pseudomonas aeruginosa urinary tract infection of a crewmember during Apollo 13. These observations indicate that the crew has the potential to be exposed to obligate and opportunistic pathogens. This risk of exposure is expected to increase with longer mission durations and increased use of regenerative life support systems. As antibiotics are the primary countermeasure after infection, determining if their efficacy during spaceflight missions is comparable to terrestrial application is of critical importance. The NASA Rotating Wall Vessel (RWV) culture system has been successfully used as a spaceflight culture analogue to identify potential alterations in several key microbial characteristics, such as virulence and gene regulation, in response to spaceflight culture. We hypothesized that bacteria cultured in the low fluid shear RWV environment would demonstrate changes in efficacy of antibiotics compared to higher fluid shear controls. This study investigated the response of three medically significant microorganisms grown in the RWV to antibiotics that could be used on spaceflight missions. Our findings suggest potential alterations in antibiotic efficacy during spaceflight and indicate that future studies on the antibiotic response require additional basic research using the RWV and/or true spaceflight. However, while this analogue has reinforced these potential alterations, the results suggest the best approach for applied forward work is evaluating an in vivo system during spaceflight, including human and rodent studies. The complex nature of the analysis for many antibiotics and organism suggests the best approach to determine in vivo responses during pharmaceutical treatment is evaluating an in vivo system during spaceflight.

Nickerson, CA↗
NASA NTRS2014

On Characterizing Particle Shape

It is well known that particle shape affects flow characteristics of granular materials, as well as a variety of other solids processing issues such as compaction, rheology, filtration and other two-phase flow problems. The impact of shape crosses many diverse and commercially important applications, including pharmaceuticals, civil engineering, metallurgy, health, and food processing. Two applications studied here include the dry solids flow of lunar simulants (e.g. JSC-1, NU-LHT-2M, OB-1), and the flow properties of wet concrete, including final compressive strength. A multi-dimensional generalized, engineering method to quantitatively characterize particle shapes has been developed, applicable to both single particle orientation and multi-particle assemblies. The two-dimension, three dimension inversion problem is also treated, and the application of these methods to DEM model particles will be discussed. In the case of lunar simulants, flow properties of six lunar simulants have been measured, and the impact of particle shape on flowability - as characterized by the shape method developed here -- is discussed, especially in the context of three simulants of similar size range. In the context of concrete processing, concrete construction is a major contributor to greenhouse gas production, of which the major contributor is cement binding loading. Any optimization in concrete rheology and packing that can reduce cement loading and improve strength loading can also reduce currently required construction safety factors. The characterization approach here is also demonstrated for the impact of rock aggregate shape on concrete slump rheology and dry compressive strength.

Ennis, Bryan J.↗
NASA NTRS2015

Method and Apparatus for a Miniature Bioreactor System for Long-Term Cell Culture

A bioreactor and method that permits continuous and simultaneous short, moderate, or long term cell culturing of one or more cell types or tissue in a laminar flow configuration is disclosed, where the bioreactor supports at least two laminar flow zones, which are isolated by laminar flow without the need for physical barriers between the zones. The bioreactors of this invention are ideally suited for studying short, moderate and long term studies of cell cultures and the response of cell cultures to one or more stressors such as pharmaceuticals, hypoxia, pathogens, or any other stressor. The bioreactors of this invention are also ideally suited for short, moderate or long term cell culturing with periodic cell harvesting and/or medium processing for secreted cellular components.

Kleis, Stanley J.↗
NASA NTRS2011

IVGEN

The Exploration Medical Capabilities Element of NASA's Human Research Program chartered the IV fluid GENeration (IVGEN) project at the NASA Glenn Research Center to develop a system that could produce IV fluid in a microgravity environment meeting USP standards. NASA's flight surgeons have identified medical conditions likely to arise during exploration missions of various length and distance from the earth. Adequately treating some of those conditions will require the ability to utilize Intravenous (IV) therapy to either serve as a method for delivering pharmaceuticals that can only be administered via that route, or to hydrate patients that are unable to hydrate themselves. Given that need, NASA currently maintains a reserve of IV fluid on ISS sufficient to treat an astronaut until they can be returned to earth, which is generally within 24 hours. Because such a rapid return will not be an designed to produce United States Pharmacopeia ( USP) grade IV fluid in a reduced gravity p option for missions extending beyond low earth orbit, NASA must either fly as many as 100 liters of IV fluid, with a total mass of 100 Kg, or provide systems that can use vehicle resources to produce such fluid if it is needed. The IVGEN hardware, a compact water purification and mixing system, was environment using available resources.

DeVon, Griffin↗
NASA NTRS2012

From Extremophiles to Star Trek, The Use of Synthetic Biology in Astrobiology

Synthetic biology – the design and construction of new biological parts and systems and the redesign of existing ones for useful purposes – has the potential to transform fields from pharmaceuticals to fuels. Our lab has focused on the potential of synthetic biology to revolutionize all three major parts of astrobiology: Where do we come from? Where are we going? and Are we alone? For the first and third, synthetic biology is allowing us to answer whether the evolutionary narrative that has played out on planet earth is likely to have been unique or universal. For example, in our lab we are re-evolving biotic functions using only the most thermodynamically stable amino acids in order to understand potential capabilities of an early organism with a limited repertoire of amino acids. In the future synthetic biology will play an increasing role in human activities both on earth, in fields as diverse as bio-mining, human health and the industrial production of novel bio-composites. Beyond earth, we will rely increasingly on biologically-provided life support, as we have throughout our evolutionary history. In order to do this, the field will build on two of the great contributions of astrobiology: studies of the origin of life and life in extreme environments.

Life in Extreme Environments↗
NASA NTRS2015

Lotus Dust Mitigation Coating and Molecular Adsorber Coating

NASA Goddard Space Flight Center has developed two unique coating formulations that will keep surfaces clean and sanitary and contain contaminants.The Lotus Dust Mitigation Coating, modeled after the self-cleaning, water-repellant lotus leaf, disallows buildup of dust, dirt, water, and more on surfaces. This coating, has been successfully tested on painted, aluminum, glass, silica, and some composite surfaces, could aid in keeping medical assets clean.The Molecular Adsorber Coating is a zeolite-based, sprayable molecular adsorber coating, designed to prevent outgassing in materials in vacuums. The coating works well to adsorb volatiles and contaminates in manufacturing and processing, such as in pharmaceutical production. The addition of a biocide would also aid in controlling bacteria levels.

protective coatings↗
NASA NTRS2016

Synthetic Astrobiology

Synthetic biology - the design and construction of new biological parts and systems and the redesign of existing ones for useful purposes - has the potential to transform fields from pharmaceuticals to fuels. Our lab has focused on the potential of synthetic biology to revolutionize all three major parts of astrobiology: Where do we come from? Where are we going? and Are we alone? For the first and third, synthetic biology is allowing us to answer whether the evolutionary narrative that has played out on planet earth is likely to have been unique or universal. For example, in our lab we are re-evolving the biosynthetic pathways of amino acids in order to understand potential capabilities of an early organism with a limited repertoire of amino acids and developing techniques for the recovery of metals from spent electronics on other planetary bodies. And what about the limits for life? Can we create organisms that expand the envelope for life? In the future synthetic biology will play an increasing role in human activities both on earth, in fields as diverse as human health and the industrial production of novel bio-composites. Beyond earth, we will rely increasingly on biologically-provided life support, as we have throughout our evolutionary history. In order to do this, the field will build on two of the great contributions of astrobiology: studies of the origin of life and life in extreme environments.

synthetic biology↗
NASA NTRS2016

Where Synthetic Biology Meets ET

Synthetic biology - the design and construction of new biological parts and systems and the redesign of existing ones for useful purposes - has the potential to transform fields from pharmaceuticals to fuels. Our lab has focused on the potential of synthetic biology to revolutionize all three major parts of astrobiology: Where do we come from? Where are we going? and Are we alone? For the first and third, synthetic biology is allowing us to answer whether the evolutionary narrative that has played out on planet earth is likely to have been unique or universal. For example, in our lab we are re-evolving the biosynthetic pathways of amino acids in order to understand potential capabilities of an early organism with a limited repertoire of amino acids and developing techniques for the recovery of metals from spent electronics on other planetary bodies. And what about the limits for life? Can we create organisms that expand the envelope for life? In the future synthetic biology will play an increasing role in human activities both on earth, in fields as diverse as human health and the industrial production of novel bio-composites. Beyond earth, we will rely increasingly on biologically-provided life support, as we have throughout our evolutionary history. In order to do this, the field will build on two of the great contributions of astrobiology: studies of the origin of life and life in extreme environments.

life in extreme environments↗
NASA NTRS2016

The Astrobiology of the Subsurface: Exploring Cave Habitats on Earth, Mars and Beyond

We are using the spectacular underground landscapes of Earth caves as models for the subsurfaces of other planets. Caves have been detected on the Moon and Mars and are strongly suspected for other bodies in the Solar System including some of the ice covered Ocean Worlds that orbit gas giant planets. The caves we explore and study include many extreme conditions of relevance to planetary astrobiology exploration including high and low temperatures, gas atmospheres poisonous to humans but where exotic microbes can flourish, highly acidic or salty fluids, heavy metals, and high background radiation levels. Some cave microorganisms eat their way through bedrock, some live in battery acid conditions, some produce unusual biominerals and rare cave formations, and many produce compounds of potential pharmaceutical and industrial significance. We study these unique lifeforms and the physical and chemical biosignatures that they leave behind. Such traces can be used to provide a "Field Guide to Unknown Organisms" for developing life detection space missions.

caves↗
NASA NTRS2015

Synthetic Astrobiology

Synthetic biology - the design and construction of new biological parts and systems and the redesign of existing ones for useful purposes - has the potential to transform fields from pharmaceuticals to fuels. Our lab has focused on the potential of synthetic biology to revolutionize all three major parts of astrobiology: Where do we come from? Where are we going? and Are we alone? For the first and third, synthetic biology is allowing us to answer whether the evolutionary narrative that has played out on planet earth is likely to have been unique or universal. For example, in our lab we are re-evolving the biosynthetic pathways of amino acids in order to understand potential capabilities of an early organism with a limited repertoire of amino acids and developing techniques for the recovery of metals from spent electronics on other planetary bodies. In the future synthetic biology will play an increasing role in human activities both on earth, in fields as diverse as human health and the industrial production of novel bio-composites. Beyond earth, we will rely increasingly on biologically-provided life support, as we have throughout our evolutionary history. In order to do this, the field will build on two of the great contributions of astrobiology: studies of the origin of life and life in extreme environments.

Potential Fields↗
NASA NTRS2016

The First Government Sanctioned Delivery of Medical Supplies by Remotely Controlled Unmanned Aerial System (UAS)

The first government sanctioned delivery of medical supplies by UAS occurred at Wise, Virginia, on July 17, 2015. The "Let's Fly Wisely" event was a demonstration of the humanitarian use of UAS to facilitate delivery of medical supplies to remote or otherwise difficult-to-reach areas. The event was the result of coordinated efforts by a partnership which included the National Aeronautics and Space Administration (NASA) Langley Research Center (LaRC), Virginia Polytechnic Institute, the Mid-Atlantic Aviation Partnership (MAAP), Flirtey Corporation, Lonesome Pine Airport, Remote Area Medical (RAM), Health Wagon, SEESPAN Aerial Interactive, Rx Partnership, and Wise County, Virginia. The historic event occurred during the annual Remote Area Medical clinic at the Wise County Fairgrounds. The medical supplies in small packages were delivered to the Wise County Fairgrounds from the Lonesome Pine Airport by UAS operated by Firtey. A larger supply of medical supplies were delivered to the Lonesome Pine Airport from the Tazewell County Airport by NASA Langley's SR22 UAS Surrogate Research aircraft. The UAS Surrogate aircraft was remotely controlled for most of the flight by a UAS Ground Control Station located at the Lonesome Pine Airport. The medical supplies were delivered from the UAS Surrogate to Flirtey for final delivery by Hex Multi-Rotor UAS in smaller packages and multiple trips to the fairgrounds. A Certificate of Authorization (COA) issued by the Federal Aviation Administration (FAA) designated the site as an authorized UAS test site. The paper will present additional details of the historic delivery of pharmaceuticals by UAS during the "Let's Fly Wisely" event. The paper will also provide details of NASA's SR22 UAS Surrogate Research aircraft. The UAS Surrogate was designed to investigate the procedures, aircraft sensors and other systems that may be required to allow Unmanned Aerial Systems (UAS) to safely operate with manned aircraft in the National Airspace System (NAS).

Howell, Charles T., III↗
NASA NTRS2017

The Research Plan: Closing the ExMC Med02 "Pharmacy" Gap

HRP Human Research Roadmap: Risk and Gap Risk of Adverse Health Outcomes and Decrements in Performance due to Inflight Medical Conditions. Med02 "Pharmacy" Gap: We do not have the capability to provide a safe and effective medication formulary for exploration missions delivering a recommendation for a chemically stable, safe, and effective medication formulary that will support the operational needs of exploration space missions research strategy evidence-based formulary and models innovative analytical tools and methodologies novel treatments and preventive measures Planned review by a panel of experts from the pharmaceutical industry, regulatory, and academic scientific communities Formulary Selection Formulary Potency and Shelf life Formulary Safety and Toxicity Novel Technology Proof-of-Concept Portable real-time chemical analysis Innovative drug development / design

Daniels, Vernie↗
NASA NTRS2017

Mobile/Modular BSL-4 Facilities for Meeting Restricted Earth Return Containment Requirements

NASA robotic sample return missions designated Category V Restricted Earth Return by the NASA Planetary Protection Office require sample containment and biohazard testing in a receiving laboratory as directed by NASA Procedural Requirement (NPR) 8020.12D - ensuring the preservation and protection of Earth and the sample. Currently, NPR 8020.12D classifies Restricted Earth Return for robotic sample return missions from Mars, Europa, and Enceladus with the caveat that future proposed mission locations could be added or restrictions lifted on a case by case basis as scientific knowledge and understanding of biohazards progresses. Since the 1960s, sample containment from an unknown extraterrestrial biohazard have been related to the highest containment standards and protocols known to modern science. Today, Biosafety Level (BSL) 4 standards and protocols are used to study the most dangerous high-risk diseases and unknown biological agents on Earth. Over 30 BSL-4 facilities have been constructed worldwide with 12 residing in the United States; of theses, 8 are operational. In the last two decades, these brick and mortar facilities have cost in the hundreds of millions of dollars dependent on the facility requirements and size. Previous mission concept studies for constructing a NASA sample receiving facility with an integrated BSL-4 quarantine and biohazard testing facility have also been estimated in the hundreds of millions of dollars. As an alternative option, we have recently conducted an initial trade study for constructing a mobile and/or modular sample containment laboratory that would meet all BSL-4 and planetary protection standards and protocols at a faction of the cost. Mobile and modular BSL-2 and 3 facilities have been successfully constructed and deployed world-wide for government testing of pathogens and pharmaceutical production. Our study showed that a modular BSL-4 construction could result in approximately 90% cost reduction when compared to traditional construction methods without compromising the preservation of the sample or Earth.

Calaway, M. J.↗
NASA NTRS2017

The Astrobiology of the Subsurface: Caves and Rock Fracture Habitats on Earth, Mars and Beyond

The Astrobiology of the Subsurface: Exploring Cave Habitats on Earth, Mars and Beyond. We are using the spectacular underground landscapes of Earth caves as models for the subsurfaces of other planets. Caves have been detected on the Moon and Mars and are strongly suspected for other bodies in the Solar System including some of the ice covered Ocean Worlds that orbit gas giant planets. The caves we explore and study include many extreme conditions of relevance to planetary astrobiology exploration including high and low temperatures, gas atmospheres poisonous to humans but where exotic microbes can fluorish, highly acidic or salty fluids, heavy metals, and high background radiation levels. Some cave microorganisms eat their way through bedrock, some live in battery acid conditions, some produce unusual biominerals and rare cave formations, and many produce compounds of potential pharmaceutical and industrial significance. We study these unique lifeforms and the physical and chemical biosignatures that they leave behind. Such traces can be used to provide a Field Guide to Unknown Organisms for developing life detection space missions.

Caves↗
NASA NTRS2018

Mobile/Modular BSL-4 Containment Facilities Integrated into a Curation Receiving Laboratory for Restricted Earth Return Missions

NASA robotic sample return missions designated Category V Restricted Earth Return by the NASA Planetary Protection (PP) Office require sample containment and biohazard testing upon return to Earth. Since the 1960s, sample containment from an unknown extraterrestrial biohazard have been related to the highest containment standards and protocols known to modern science. Today, this is Biosafety Level (BSL) 4 containment. In the U.S., the Biosafety in Microbiological and Biomedical Laboratories publication authored by the U.S. Department of Health and Human Services (HHS): Public Health Service, Centers for Disease Control and Prevention, and the National Institutes of Health houses the primary recommendations, standards, and design requirements for all BSL labs. Past mission concept studies for constructing a NASA Curation Receiving Laboratory with an integrated BSL-4 quarantine and biohazard testing facility have been estimated in the hundreds of millions of dollars (USD). As an alternative option, we have conducted a trade study for constructing a mobile and/or modular sample containment laboratory that would meet all BSL-4 and planetary protection standards and protocols at a fraction of the cost. Mobile and modular BSL-2 and 3 facilities have been successfully constructed and deployed world-wide for government testing of pathogens and pharmaceutical production. Our study showed that a modular BSL-4 construction could result in ~ 90% cost reduction when compared to traditional BSL-4 construction methods without compromising the preservation of the samples or Earth. For the design/construction requirements of a mobile/modular BSL-4 containment, we used the established HHS document standards and protocols for manipulation of agents in Class III Biosafety Cabinets (BSC; i.e., negative pressure gloveboxes) that are currently followed in operational BSL-4 facilities in the U.S.

Calaway, Michael J.↗