Search

Background: The susceptibility of the most common causative pathogens drives empiric initial antibiotic therapy for bacterial infections. This cross-sectional study was conducted to detect the infection trends and antibiotic susceptibility patterns of patients attending the Burdwan medical college and hospital (BMCH), West Bengal. Methodology: A prospective study was conducted for six months, from August 2021 to January 2022, at the department of microbiology (BMCH), West Bengal. Isolation of bacteria and fungus was performed from clinical samples obtained from patients attending the department of the ear, nose, and throat (ENT) of BMCH. A total of 84 samples were collected from patients with suspected ENT infections. Types of samples taken include pus, fluid, tissue, and throat, nasal, and ear swabs. Results: Bacterial growth was observed in 55(65.47%), of which gram-positive and gram-negative bacterial isolates were found in 31(56.36%) and 21(38.18%) samples, respectively. 3(5.45%) gram-positive bacilli were grown, and 14(16.66%) samples were positive for fungal growth. Conclusion: Antibiogram of gram-positive isolates showed maximum susceptibility to vancomycin and least to ciprofloxacin, whereas gram-negative isolates showed maximum susceptibility to amikacin and least to ciprofloxacin.

The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term “Context of Use – COU”); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and, critical reagent and positive control generation were the special features of the 15th edition. This 2021 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparabil ity & Cut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 10 and 11 (2022), respectively.

With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency provided the agencies' perspectives on the challenges in ensuring data quality in novel clinical trial designs and the importance of the management and documentation of protocol deviations, sponsor oversight of clinical trials, and use of electronic source data, including electronic health records. This paper summarizes considerations of both agencies on these topics, along with case examples. This paper touches upon considerations when using real-world data to support regulatory decisions. It also discusses the impact of the coronavirus disease 2019 (COVID-19) pandemic on clinical trial conduct and underscores the importance of well-designed, resilient, and adaptable systems for GCP compliance and data integrity.

The mechanical exfoliation of naturally occurring layered materials has emerged as an easy and effective method for achieving ultrathin van der Waals (vdW) heterostructures with well-defined lattice orientations of the constituent two-dimensional (2D) material layers. Cylindrite is one such naturally occurring vdW heterostructure, where the superlattice is composed of alternating stacks of SnS2-like and PbS-like layers. Although the constituent 2D lattices are isotropic, inhomogeneous strain occurring from local atomic alignment for forcing the commensuration makes the cylindrite superlattice structurally anisotropic. Here, we demonstrate the highly anisotropic optical responses of cylindrite thin flakes induced by the anisotropic crystal structure, including angle-resolved polarized Raman scattering, linear dichroism, and polarization-dependent anisotropic third-harmonic generation. Our results provide a promising approach for identifying various natural vdW heterostructure-based 2D materials with tailored optical properties and can be harnessed for realizing anisotropic optical devices for on-chip photonic circuits and optical information processing.

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15–29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.

The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term "Context of Use - COU"); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and, critical reagent and positive control generation were the special features of the 15th edition. This 2021 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, GeneCell Therapy and Vaccine. Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/OralMultispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9CAR-T Immunogenicity; PCRVaccine Assay Performance; ADA Assay Comparabil ityCut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 10 and 11 (2022), respectively.

The capability of controlling the phase of the nonlinear polarization of media is vital for nonlinear optical beam shaping. Achieving this control over nonlinear phase manipulation on the nanoscale...

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in clinical trials and to assure the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. The first joint GCP workshop of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA-UK) was held in October 2018 and provided the agencies' perspectives on the importance of data quality management practices on data integrity. Regulatory perspectives on data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials were discussed. This paper summarizes considerations of both agencies on these topics, along with case examples.

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1–5 April 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on the 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy. Part 1 (Innovation in small molecules and oligonucleotides and mass spectrometry method development strategies for large molecules bioanalysis) and Part 3 (New insights in biomarker assay validation, current and effective strategies for critical reagent management, flow cytometry validation in drug discovery and development and CLSI H62, interpretation of the 2019 FDA immunogenicity guidance and gene therapy bioanalytical challenges) are published in volume 10 of Bioanalysis, issues 22 and 24 (2019), respectively.

Wavelength, polarization and orbital angular momentum of light are important degrees of freedom for processing and encoding information in optical communication. Over the years, the generation and conversion of orbital angular momentum in nonlinear optical media has found many novel applications in the context of optical communication and quantum information processing. With that hindsight, here orbital angular momentum conversion of optical vortices through second-harmonic generation from only one atomically thin WS2 monolayer is demonstrated at room temperature. Moreover, it is shown that the valley-contrasting physics associated with the nonlinear optical selection rule in WS2 monolayer precisely determines the output circular polarization state of the generated second-harmonic vortex. These results pave the way for building future miniaturized valleytronic devices with atomic-scale thickness for many applications such as chiral photon emission, nonlinear beam generation, optoelectronics, and quantum computing.

As greenhouse gases threaten our environment, it has become increasingly necessary to replace consumption of fossil fuels with renewable energy. Without energy storage, solar cannot provide power at night during times of peak demand, resulting in a gap between supply capabilities and demand. Solar thermochemical energy storage (TCES) has potential to resolve this critical temporal issue. An 800MWhth TCES subsystem has been designed to cost-effectively convert solar energy to electricity. An evaluation of each required component is provided, including the reactor chemistry. Strontium carbonate decomposition is used to densely store high temperature thermal energy via chemical reaction, while two different CO2 storage methods are considered. To determine the practical feasibility of these schemes, a probabilistic analysis has been performed to explore exergy and energy efficiency, and cost. It has been found that a scheme storing CO2 via sorbents is capable of ∼71% energy and ∼87% exergy efficiency, and an installed cost of ∼48 USD kWhth−1.

The 14

Tamul Plates Marketing Private Limited (TPMC) is a four-year-old organization in the production of aercanut sheath based plates and dinnerware. It is jointly promoted by the arecanut leaf plate producers of Assam. The main work of TPMC is production and marketing of disposable plates and marketing of the leaf plate making machines. The initial journey has been pretty exciting with the organization moving from a turnover of INR 12.9 lakh to over INR 2 corers. The products offered by TPMC are unique as they make use of fallen sheaths which traditionally have been considered a waste, and turn them into an environment-friendly product which is superior to the current substitutes in the market. The market for the product is enormous, but so are the challenges of producing and marketing them. One of the many challenges which TPMC is facing is the location of the production facilities. It has been decided for production facilities to be closest to the source of raw materials, that is, the villages. However, the most lucrative markets are farthest from the source of raw material and matching the demand patterns and preferences is not easy. TPMC is taking care of this challenge by setting up entrepreneurs at the village level, but marketing and distribution remains a challenge with the reliance on wholesalers being very heavy. TPMC is preparing for the next round of growth with the expected funding around the corner. The team has done their projections and set the typical growth targets for the next phase. However, along with the typical growth targets, TPMC has also identified the triple bottom line targets for the organization. The overall growth plan has to be seen in the light of these goals as they are expected to become more and more relevant to all companies in the future.

Basic services such as safe drinking water, proper garbage disposals, adequate sewage systems, sufficient street lighting and strong infrastructure in places like schools and hospitals, among others are all fundamental prerequisites to a decent urban life. Yet, the vastly increasing rural-to-urban migration, as is common in developing countries today, presents intricate difficulties for local urban bodies, as they struggle to accommodate and provide basic services to a rapidly increasing population. Efficiency in managing and maintaining urban infrastructure, combined with adequate public services and full citizen accountability, defines the quality of any urban government. In this context, the present paper tries to evaluate the performance and public role of urban governance as concerns selected wards of the Chandernagore Municipal Corporation (CMC). The CMC was chosen due to its status as the fifth-ranked city among Class-I cities situated in the west bank of the Hooghly River (within the Kolkata Metropolitan Area). As this is the oldest municipal corporation in West Bengal, is located only 35 km north of Kolkata and is a densely populated urban area (with a population density of 8800 person/km2), the demand for efficient and adequate basic services is an enormous challenge. In this paper, the evaluation of basic services has been done through the application of The Urban Governance Initiative (TUGI) index, an index based on the judgement of citizens’ regarding the performance by urban services. The study also tries to focus on new initiatives by the CMC—such as the Citizen Charter—in order to inform citizens about institutional targets regarding the supply and maintenance of basic services as well as future plans regarding the expansion and improvement of these services.

Nonlinear holography enables optical beam generation and holographic image reconstruction at new frequencies other than the excitation fundamental frequency, providing pathways toward unprecedented applications in optical information processing and data security. So far, plasmonic metasurfaces with the thickness of tens of nanometers have been mostly adopted for realizing nonlinear holograms with the potential of on-chip integration but suffering from low conversion efficiency and high absorption loss. Here, we report a nonlinear transition metal dichalcogenide (TMD) hologram with high conversion efficiency and atomic thickness made of only single nanopatterned tungsten disulfide (WS

The localized interaction between metallic nanostructures and surrounding fluorescent molecules can influence the emission characteristics of the molecule. With this hindsight, herein, by employing a Fourier optical fluorescence microscope, we experimentally show how fluorescence emission from molecules in the vicinity of a chemically prepared silver nanowire-dimer-junction can be directed in one or two channels. Measured forward-to-backward ratio of the fluorescence emission in a single channel was as high as 4.3 dB, and the observed polar and azimuthal angular spread was as narrow as 15° and 60°, respectively. Interestingly, the angle between the two emission channels mimicked the angle between the nanowires, thus, highlighting the prospect of geometrical control of the emitted light. These observations were further corroborated by three-dimensional finite-difference time-domain simulations. The presented results will have implications in momentum-space engineering of molecular fluorescence emission and...

Provisioning of virtual machines for efficient geospatial query management on cloud is an interesting and challenging work. The aim of this paper is to distribute workloads of different types of spatial queries into suitable virtual machine efficiently. To increase the effectiveness of the system serving geospatial queries, we use real-time geospatial query pattern learning methodology. This methodology is used to train the application specific properties, and the system will learn which type of the geospatial query should be allocated to what type of virtual machine automatically. The learning methodology gives knowledge about the resource required by each type of geospatial query. Using this understanding, various geospatial query templates are stored in the query template repository for further assistance. By this way, fast and robust assignment of virtual machine for the geospatial queries is possible which reduces their waiting time.

Background: Electrically controlled optical metal antennas are an emerging class of nanodevices enabling a bilateral transduction between electrons and photons. At the heart of the device is a tunnel junction that may either emit light upon injection of electrons or generate an electrical current when excited by a light wave. The current study explores a technological route for producing these functional units based upon the electromigration of metal constrictions.Results: We combine multiple nanofabrication steps to realize in-plane tunneling junctions made of two gold electrodes, separated by a sub-nanometer gap acting as the feedgap of an optical antenna. We electrically characterize the transport properties of the junctions in the light of the Fowler–Nordheim representation and the Simmons model for electron tunneling. We demonstrate light emission from the feedgap upon electron injection and show examples of how this nanoscale light source can be coupled to waveguiding structures.Conclusion: Electromigrated in-plane tunneling optical antennas feature interesting properties with their unique functionality enabling interfacing electrons and photons at the atomic scale and with the same device. This technology may open new routes for device-to-device communication and for interconnecting an electronic control layer to a photonic architecture.

Single-molecule surface-enhanced Raman scattering (SM-SERS) is one of the vital applications of plasmonic nanoparticles. The SM-SERS sensitivity critically depends on plasmonic hot-spots created at the vicinity of such nanoparticles. In conventional fluid-phase SM-SERS experiments, plasmonic hot-spots are facilitated by chemical aggregation of nanoparticles. Such aggregation is usually irreversible, and hence, nanoparticles cannot be re-dispersed in the fluid for further use. Here, we show how to combine SM-SERS with plasmon polariton-assisted, reversible assembly of plasmonic nanoparticles at an unstructured metal–fluid interface. One of the unique features of our method is that we use a single evanescent-wave optical excitation for nanoparticle assembly, manipulation and SM-SERS measurements. Furthermore, by utilizing dual excitation of plasmons at metal–fluid interface, we create interacting assemblies of metal nanoparticles, which may be further harnessed in dynamic lithography of dispersed nanostructures. Our work will have implications in realizing optically addressable, plasmofluidic, single-molecule detection platforms. Plasmonic hot-spot generation in solution is not reversible for single-molecule surface-enhanced Raman scattering, which limits its applications. Patra et al.tackle this problem by integrating this technique with thermo-plasmon-assisted reconfiguration of nanoparticles at a metal–fluid interface.

The volunteered geographic information has been considered as a valuable source of information for disaster management. It may provide rapid essential information from the disaster area. However, this information has been generated by general people without any knowledge in spatial data concept. It is found that the quality of volunteered data have not considered for any emergency decision making. In the work, a statistical framework has been developed to validate the citizen generated spatial data for emergency decision making.

Motivated by recent experiments on electrochemically controlled Pb atomic-scale switches we have studied the self-diffusion of Pb on flat and stepped surfaces since diffusion processes play an important role in the growth of metal substrates. Kinetic modelling based on Monte-Carlo simulations using a model potential suggests that exchange processes play an important role in the contact formation at the nanoscale. Periodic density functional theory indeed find that the barriers for exchange diffusion across the steps are significantly lower than for hopping diffusion. The consequences for the contact formation in electrochemically controlled switches are discussed.