War and peace: assessing the impact of PMC\u27s on the outcome of civil conflicts

As a response to the proliferation of private military contractors (PMC\u27s) operating in the global marketplace today, scholars have increased the range and scope of their studies on PMC\u27s. Yet, to date there exists no body of literature that provides a comprehensive examination of how PMC\u27s may potentially impact the outcome to a civil conflict. My essay establishes that PMC\u27s may play very different roles within conflicts, which influence the outcome to a conflict, and does so by examining the cases of Military Professional Resources, Incorporated (MPRI) in the Balkans, Executive Outcomes (EO) in Angola and EO in Sierra Leone

Formal and Functional Linguistic Properties of ESL Textbooks

Based on the formal and functional perspectives espoused in Systemic Functional Linguistics (SFL), the main purpose of this thesis was to investigate the extent to which such lexico-grammatical features as lexical density, choice of nominal groups, and grammatical metaphor are used in ESL texts to scaffold target language proficiency levels. Of the number of lexico-grammatical metafunctions and their functional constituents, interpersonal metafunctional categories were analyzed from these three functional features in this thesis in order to reveal the ways in which interpersonal categories and the lexico-grammatical features are correlated as the level of difficulty of each text increases. The analysis shows that sequential deployment of functional meanings and categories is a crucial feature in the way that ESL texts develop levels of complexity of the target language. This analysis then provides suggestive evidence that because of the significance of these functional grammatical features in science-based genre texts, incorporating more functional grammar approaches to teaching ESL, especially in teaching reading comprehension, might prove to be a more effective teaching strategy than traditional formal grammar approaches allow

Streptavidin-biotin binding of DNA amplicons: methods for the typing and re-typing of forensically relevant short tandem repeats

Thesis (M.S.)--Boston UniversitySubmission of evidentiary samples to DNA units for exhaustive testing is becoming commonplace. For these samples, only one attempt at amplification is possible. However, more than one amplification may be necessary if the condition of the DNA causes poor amplification, more than one type of STR kit testing is required, or if there is an instrument malfunction during amplification. Current research into the re-amplification of already amplified samples focuses on placing the PCR product back into the thermal cycler with new reagents for additional cycles. These methods typically result in outcomes which are unsatisfactory for forensic purposes. As a result, there is a need for a forensic method capable of recovering the original template DNA for purposes of re-amplification. This study outlines the development of a novel method to recover the original template DNA in a condition that allows for re-amplification using new STR loci. A dynamic model was designed to assist in the experimental optimization. Amplification was performed using biotinylated primers and the post PCR 'work product' was subsequently cleaned using streptavidin coated magnetic beads to remove the STR amplicons. Centrifugal filtration followed in order to remove any remaining primers and salts that may interfere with re-amplification. Re-amplification was then performed with non-biotinylated primers. Re-amplification of the template DNA using a new STR locus was successful, making the amplification of limited DNA samples non-destructive and the notion of 'exhaustive DNA typing' obsolete

BPOG model solvent comparison for extractables testing for single use systems

Regulatory guidance requires an extractables based evaluation for drug manufacturing processes. Concerns about the increasing use of hyrbrid and fully single use systems in manufacturing processes and what they may contribute the bulk drug substance and final drug product has highlighted the need for thorough risk assessments and safety evaluations. Awareness of the risk each unit operation represents a strategy to deal with the risk is crucial. An outline of a manufacturing process will be presented along with each unit operations potential risk. This discussion will define an extractables testing strategy based upon the Biophorum Operations Group (BPOG) Extractables Protocol for the highest risk process step - sterilizing filtration in a point of use filling line application that is in direct contact with drug product. Analytical results from multiple methods for six model solvent streams will be shown: water, 0.5N NaOH, 0.1 M Phosphoric Acid, 50% Denatured Ethanol/ 50% Water mixture, 1% Polysorbate 80 and 5M NaCL; using time points of \u3c30 \u3eminutes, 24 hours and 7 days. A comparison of the compounds identified by each method, solvent and time point will presented. The extractables data from the sterilizing grade filter will be used to perform a patient safety evaluation for a typical process and a representative drug product. The calculated extractables concentration per dose will be compared to the Permissible Daily Exposure (PDE) level for individual compounds

The practical application of BPOG E&L protocols to viral clearance filters

Regulatory guidance advocates virus control at various stages of the drug manufacturing process and directs that you test the capacity of the process to remove or inactivate virus. Patient safety concerns require you to determine what impurities may be added by the virus control steps you implement. While the application of a standardized approach to identifying and quantifying the extractables from these steps has benefits when making comparisons, choices have to be made when developing the protocol that take into account the characteristics of the clearance device and use conditions This presentation will illustrate the practical implementation of standardized extractables method on an industry leading viral clearance technology by explaining the rational for the selection of extraction solvents; extraction conditions and sampling points. Data generated during the study will be presented as well as lessons learned in implementing the new protocol

Assessing the impact of single use systems on patient safety

Single use process technology is routinely used in the manufacture of pharmaceuticals and biopharmaceuticals. The potential for extractables and leachables from single use systems and their impact on patient safety are an important focus of drug manufacturers and regulators. While current regulatory guidelines and industry standards provide general direction on compound-specific safety assessments, they do not offer a comprehensive approach to safety evaluations of extractables and leachables. Smaller, emerging companies might not even be aware of the extent of the extractables and leachables data expected by regulatory authorities and that the FDA has issued warning letters in cases where the appropriate extractables and leachables studies were missing for a drug product. The authors will describe a comprehensive approach to determine the impact single use process technology has on patient safety

Risk-based qualification of X-ray sterilization for single-use systems

The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation warrants consideration as an alternate sterilization technology. X-ray irradiation offers better penetration characteristics, improved dose uniformity ratio (DUR), and less environmental impact when compared to other sterilization modalities. We will share a risk based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization modalities

7. Habitat Use and Home Range of Eastern Box Turtle (Terrapene carolina carolina) in North Georgia Piedmont

The Eastern Box Turtle (Terrapene carolina carolina) is a terrestrial species native to the eastern United States. Eastern Box Turtles are experiencing range-wide population decline and are classified as vulnerable by the International Union for the Conservation of Nature. Despite this, little research has been conducted regarding home range and habitat use in the Southeastern US. Therefore, since May 2013, we have conducted a radiotelemetry study to investigate factors that influence Box Turtle movement, habitat use, and survival in the Northeastern Piedmont region of Georgia. The study site is composed of mixed hardwood-pine uplands primarily comprised of oaks and maples, mesic and upland areas dominated by Chinese privet (Ligustrum sinense), beaver-created wetland, and maintained utility line areas. Our research includes 21 radio-transmitted turtles that are tracked on foot by homing 1-2 times a week. From spring 2013 to winter 2017, an average of 74 radiolocations (range: 6 to 166) per turtle were collected. Home ranges (100% minimum convex polygon) varied from less than 1 to over 6 ha. Radiotracked turtles primarily used mixed-upland areas and areas dominated by Chinese privet. The assessment of habitat use and home ranges will continue throughout 2017 with tracking and further data analysis. Keywords: Terrapene carolina carolina, radiotelemetry, home range, habitat use, Ligustrum sinens

Adopting a fully single-use process to improve speed to clinic: A leachables case study

The implementation of single-use technologies for pharmaceutical product development continues to gain momentum; this trend is due to the advantages of increased flexibility, speed of implementation and lower capital investment In particular, they are seen as a means to accelerate the production of material for clinical trials. However, a primary concern regarding the use of such technologies is the impact leachables on patient safety in the final drug substance. Typically this concern is addressed through a patient safety evaluation utilizing extractable substances data based on model solvent extractions and from individual components and devices. However, little if any data has been published where leachables are evaluated under actual process conditions through a complete single-use clinical-scale process train. We have addressed this by completing a pilot scale 100 L “mock” mAb production and purification where the cells, and hence mAb protein, are absent but where the bioreactor was run for the normal duration with cell culture media and feeds, and the DSP train utilized all the standard process devices, buffers, conditions, and procedures. Data will be presented on the leachables profile throughout the entire production process the result of a patient safety evaluation conducted on the bulk drug substance after storage

Static vs. dynamic extraction – Comparing best practice for Single Use Technology

Which is the more discriminating method for single use technology– static or dynamic extraction? Discussion among industry groups and subject matter experts has been intense. However, very little data exist comparing the two techniques. This presentation will present the findings of a side-by-side study that compares the extractables generated from gamma irradiated 10” filters using each technique. The discussion will compare and contrast the profiles of the total organic carbon (TOC), volatile organic compounds (VOCs), semi-volatile organic compounds (SVOCs), pH, and metals extracted. The discussion will compare the profiles with time for each technique for each analysis, as well as summarize the pros and cons of each technique