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Room-temperature longwave infrared (LWIR) detectors are preferred over cryogenically cooled solutions due to the cost effectiveness and ease of operation. The performance of present uncooled LWIR detectors such as microbolometers, is limited by reduced sensitivity, slow response time, and the lack of dynamic spectral tunability. Here, we present a graphene-based efficient room-temperature LWIR detector with high detectivity and fast response time utilizing its tunable optical and electronic characteristics. The inherent weak light absorption is enhanced by Dirac plasmons on the patterned graphene coupled to an optical cavity. The absorbed energy is converted into photovoltage by the Seebeck effect with an asymmetric carrier generation environment. Further, dynamic spectral tunability in the 8-12 µm LWIR band is achieved by electrostatic gating. The proposed detection platform paves the path to a fresh generation of uncooled graphene-based LWIR photodetectors for wide ranging applications such as molecular sensing, medical diagnostics, military, security and space.
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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 (WS2) monolayer, for producing optical vortex beams and Airy beams as well as reconstructing complex holographic images at the second harmonic (SH) frequency. Our concept of nonlinear TMD holograms paves the way toward not only the understanding of light-matter interactions at the atomic level but the integration of functional TMD-based devices with atomic thickness into the next-generation photonic circuits for optical communication, high-density optical data storage, and information security.
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We experimentally show how a single Ag nanoparticle (NP) coupled to an Ag nanowire (NW) can convert propagating surface plasmon polaritons to directional photons. By employing dual-excitation Fourier microscopy with spatially filtered collection-optics, we show single- and dual-directional out-coupling of light from NW-NP junction for plasmons excited through glass-substrate and air-superstrate. Furthermore, we show NW-NP junction can influence the directionality of molecular-fluorescence emission, thus functioning as an optical antenna. The results discussed herein may have implications in realizing directional single-photon sources and quantum plasmon circuitry.
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The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th 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 the ICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2022 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 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Mass Spectrometry and ICH M10. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (LBA, Biomarkers/CDx and Cytometry) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 15 of Bioanalysis, issues 15 and 14 (2023), respectively.
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Cromatografia , Vacinas , Biomarcadores , Terapia Baseada em Transplante de Células e Tecidos , Espectrometria de Massas , Oligonucleotídeos , TecnologiaRESUMO
Plasmonic nanodimers facilitate electromagnetic hotspots at their gap junction. By loading these gap junctions with nanomaterials, the plasmonic properties of nanodimer can be varied. In this study, we bridged the gap junction of gold (Au) nanocylinder dimer with palladium (Pd), and numerically evaluated the plasmonic properties of the designed nanostructure. We simulated the far-field extinction spectra of Pd bridged Au nanocylinder dimer, and identified the dipole and quadrupole plasmon modes at 839 and 578 nm, respectively. By varying the geometrical parameters of the Pd bridge, we revealed the ability to tune the dipolar plasmon resonance of the bridged dimer. Further, we exploited the hydrogen sensitivity of Pd bridge to harness the bridged-Au dimer as nanoplasmonic hydrogen sensor. Such nano-optical detection platforms have minimal spatial footprint and can be further harnessed for chip-based plasmonic sensing.
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Cannizzarite is a naturally occurring mineral formed by van der Waals (vdW) stacking of alternating layers of PbS-like and Bi2S3-like two-dimensional (2D) materials. Although the PbS-type and Bi2S3-type 2D material layers are structurally isotropic individually, the forced commensuration between these two types of layers while forming the heterostructure of cannizzarite induces strong structural anisotropy. Here we demonstrate the mechanical exfoliation of natural cannizzarite mineral to obtain thin vdW heterostructures of PbS-type and Bi2S3-type atomic layers. The structural anisotropy induced anisotropic optical properties of thin cannizzarite flakes are explored through angle-resolved polarized Raman scattering, linear dichroism, and polarization-dependent anisotropic third-harmonic generation. Our study establishes cannizzarite as a new natural vdW heterostructure-based 2D material with highly anisotropic optical properties for realizing polarization-sensitive linear and nonlinear photonic devices for future on-chip optical computing and optical information processing.
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The design and formation of van der Waals (vdW) heterostructures with different two-dimensional (2D) materials provide an opportunity to create materials with extraordinary physical properties tailored toward specific applications. Mechanical exfoliation of natural vdW materials has been recognized as an effective way for producing high-quality ultrathin vdW heterostructures. Abramovite is one of such naturally occurring vdW materials, where the superlattice is composed of alternating Pb2BiS3 and SnInS4 2D material lattices. The forced commensuration between the two incommensurate constituent 2D material lattices induces in-plane structural anisotropy in the formed vdW heterostructure of abramovite, even though the individual 2D material lattices are isotropic in nature. Here, we show that ultrathin layers of vdW heterostructures of abramovite can be achieved by mechanical exfoliation of the natural mineral. Furthermore, the structural anisotropy induced highly anisotropic vibrational and optical responses of abramovite thin flakes are demonstrated by angle-resolved polarized Raman scattering, linear dichroism, and polarization-dependent third-harmonic generation. Our results not only establish abramovite as a promising natural vdW material with tailored linear and nonlinear optical properties for building future anisotropic integrated photonic devices, but also provide a deeper understanding of the origin of structural, vibrational and optical anisotropy in vdW heterostructures.
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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.
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COVID-19 , Órgãos Governamentais , Humanos , Pandemias , Reino Unido , Estados Unidos , United States Food and Drug AdministrationRESUMO
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.
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Vesículas Extracelulares , Vacinas , Biomarcadores/análise , Terapia Baseada em Transplante de Células e Tecidos , Vesículas Extracelulares/química , Humanos , Espectrometria de Massas/métodos , NanomedicinaRESUMO
Transcription consists of a series of highly regulated steps: assembly of the preinitiation complex (PIC) at the promoter, initiation, elongation, and termination. PIC assembly is nucleated by TFIID, a complex composed of the TATA-binding protein (TBP) and a series of TBP-associated factors (TAFs). One component, TAF7, is incorporated in the PIC through its interaction with TFIID but is released from TFIID upon transcription initiation. We now report that TAF7 interacts with the transcription factors, TFIIH and P-TEFb, resulting in the inhibition of their Pol II CTD kinase activities. Importantly, in in vitro transcription reactions, TAF7 inhibits steps after PIC assembly and formation of the first phosphodiester bonds. Further, in vivo TAF7 coelongates with P-TEFb and Pol II downstream of the promoter. We propose a model in which TAF7 contributes to the regulation of the transition from PIC assembly to initiation and elongation.
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Regulação da Expressão Gênica , Fator B de Elongação Transcricional Positiva/metabolismo , Fatores Associados à Proteína de Ligação a TATA/metabolismo , Fatores Associados à Proteína de Ligação a TATA/fisiologia , Fator de Transcrição TFIID/metabolismo , Fator de Transcrição TFIIH/metabolismo , Linhagem Celular , Humanos , Complexos Multiproteicos , Ligação Proteica , Fator de Transcrição TFIID/fisiologia , Transcrição Gênica , TransfecçãoRESUMO
Although pathways for assembly of RNA polymerase (Pol) II transcription preinitiation complexes (PICs) have been well established in vitro, relatively little is known about the dynamic behavior of Pol II general transcription factors in vivo. In vitro, a subset of Pol II factors facilitates reinitiation by remaining very stably bound to the promoter. This behavior contrasts markedly with the highly dynamic behavior of RNA Pol I transcription complexes in vivo, which undergo cycles of disassembly/reassembly at the promoter for each round of transcription. To determine whether the dynamic behavior of the Pol II machinery in vivo is fundamentally different from that of Pol I and whether the static behavior of Pol II factors in vitro fully recapitulates their behavior in vivo, we used fluorescence recovery after photobleaching (FRAP). Surprisingly, we found that all or nearly all of the TATA-binding protein (TBP) population is highly mobile in vivo, displaying FRAP recovery rates of <15 s. These high rates require the activity of the TBP-associated factor Mot1, suggesting that TBP/chromatin interactions are destabilized by active cellular processes. Furthermore, the distinguishable FRAP behavior of TBP and TBP-associated factor 1 indicates that there are populations of these molecules that are independent of one another. The distinct FRAP behavior of most Pol II factors that we tested suggests that transcription complexes assemble via stochastic multistep pathways. Our data indicate that active Pol II PICs can be much more dynamic than previously considered.
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Saccharomyces cerevisiae/citologia , Saccharomyces cerevisiae/metabolismo , Proteína de Ligação a TATA-Box/metabolismo , Mutação/genética , Fotodegradação , Saccharomyces cerevisiae/genética , Saccharomyces cerevisiae/efeitos da radiação , Proteína de Ligação a TATA-Box/genéticaRESUMO
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.
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Bioensaio/métodos , Terapia Baseada em Transplante de Células e Tecidos/métodos , Terapia Genética/métodos , Espectrometria de Massas/métodos , História do Século XXI , HumanosRESUMO
Mot1 is an essential, conserved, TATA-binding protein (TBP)-associated factor in Saccharomyces cerevisiae with well-established roles in the global control of RNA polymerase II (Pol II) transcription. Previous results have suggested that Mot1 functions exclusively in Pol II transcription, but here we report a novel role for Mot1 in regulating transcription by RNA polymerase I (Pol I). In vivo, Mot1 is associated with the ribosomal DNA, and loss of Mot1 results in decreased rRNA synthesis. Consistent with a direct role for Mot1 in Pol I transcription, Mot1 also associates with the Pol I promoter in vitro in a reaction that depends on components of the Pol I general transcription machinery. Remarkably, in addition to Mot1's role in initiation, rRNA processing is delayed in mot1 cells. Taken together, these results support a model in which Mot1 affects the rate and efficiency of rRNA synthesis by both direct and indirect mechanisms, with resulting effects on transcription activation and the coupling of rRNA synthesis to processing.
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DNA Helicases/metabolismo , RNA Ribossômico/biossíntese , Proteínas de Saccharomyces cerevisiae/metabolismo , Saccharomyces cerevisiae/metabolismo , Fatores Associados à Proteína de Ligação a TATA/metabolismo , Adenosina Trifosfatases/metabolismo , Cromatina/metabolismo , DNA Ribossômico/ultraestrutura , Regulação Fúngica da Expressão Gênica , Genes Fúngicos , Mutação/genética , Regiões Promotoras Genéticas/genética , Transporte Proteico , RNA Polimerase I/metabolismo , Processamento Pós-Transcricional do RNA/genética , RNA Ribossômico/genética , RNA Ribossômico/ultraestrutura , Sequências Repetitivas de Ácido Nucleico/genética , Saccharomyces cerevisiae/citologia , Saccharomyces cerevisiae/genética , Saccharomyces cerevisiae/ultraestrutura , Fatores de Transcrição/metabolismo , Transcrição GênicaRESUMO
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.
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Ensaios Clínicos como Assunto/normas , Gerenciamento de Dados/normas , Aprovação de Drogas , Projetos de Pesquisa/normas , United States Food and Drug Administration , Segurança Computacional/normas , Confiabilidade dos Dados , Coleta de Dados/normas , Europa (Continente) , Humanos , Estudos Multicêntricos como Assunto , Estados UnidosRESUMO
Human T-lymphotropic virus type 1 (HTLV-1) is the etiologic agent for adult T-cell leukemia. The HTLV-1-encoded protein Tax transactivates the viral long terminal repeat and plays a critical role in virus replication and transformation. Previous work from our laboratory demonstrated that coactivator-associated arginine methytransferase 1, a protein arginine methytransferase, was important for Tax-mediated transactivation. To further investigate the role of methyltransferases in viral transcription, we utilized adenosine-2,3-dialdehyde (AdOx), an adenosine analog and S-adenosylmethionine-dependent methyltransferase inhibitor. The addition of AdOx decreased Tax transactivation in C81, Hut102, and MT-2 cells. Unexpectedly, we found that AdOx potently inhibited the growth of HTLV-1-transformed cells. Further investigation revealed that AdOx inhibited the Tax-activated NF-kappaB pathway, resulting in reactivation of p53 and induction of p53 target genes. Analysis of the NF-kappaB pathway demonstrated that AdOx treatment resulted in degradation of the IkappaB kinase complex and inhibition of NF-kappaB through stabilization of the NF-kappaB inhibitor IkappaBalpha. Our data further demonstrated that AdOx induced G(2)/M cell cycle arrest and cell death in HTLV-1-transformed but not control lymphocytes. These studies demonstrate that protein methylation plays an important role in NF-kappaB activation and survival of HTLV-1-transformed cells.
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Apoptose , Ciclo Celular/efeitos dos fármacos , Proliferação de Células/efeitos dos fármacos , Inibidores Enzimáticos/farmacologia , Vírus Linfotrópico T Tipo 1 Humano/fisiologia , Metiltransferases/antagonistas & inibidores , Replicação Viral/fisiologia , Linhagem Celular , Produtos do Gene tax/metabolismo , Humanos , Quinase I-kappa B/metabolismo , Proteínas I-kappa B , Metiltransferases/fisiologia , Inibidor de NF-kappaB alfa , NF-kappa B/metabolismo , Proteína Supressora de Tumor p53/biossínteseRESUMO
Human T-cell leukemia virus type 1 (HTLV-1) is the etiologic agent of the aggressive and fatal disease adult T-cell leukemia. Previous studies have demonstrated that the HTLV-1-encoded Tax protein inhibits the function of tumor suppressor p53 through a Tax-induced NF-kappaB pathway. Given these attributes, we were interested in the activity of small-molecule inhibitor 9-aminoacridine (9AA), an anticancer drug that targets two important stress response pathways, NF-kappaB and p53. In the present study, we have examined the effects of 9AA on HTLV-1-transformed cells. Treatment of HTLV-1-transformed cells with 9AA resulted in a dramatic decrease in cell viability. Consistent with these results, we observed an increase in the percentage of cells in sub-G(1) and an increase in the number of cells positive by terminal deoxynucleotidyltransferase-mediated dUTP-biotin nick end labeling assay following treatment of HTLV-1-transformed cells with 9AA. In each assay, HTLV-1-transformed cells C8166, Hut102, and MT2 were more sensitive to treatment with 9AA than control CEM and peripheral blood mononuclear cells. Analyzing p53 function, we demonstrate that treatment of HTLV-1-transformed cells with 9AA resulted in an increase in p53 protein and activation of p53 transcription activity. Of significance, 9AA-induced cell death could be blocked by introduction of a p53 small interfering RNA, linking p53 activity and cell death. These results suggest that Tax-repressed p53 function in HTLV-1-transformed cells is "druggable" and can be restored by treatment with 9AA. The fact that 9AA induces p53 and inhibits NF-kappaB suggests a promising strategy for the treatment of HTLV-1-transformed cells.
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Aminacrina/farmacologia , Anticarcinógenos/farmacologia , Vírus Linfotrópico T Tipo 1 Humano/fisiologia , Proteína Supressora de Tumor p53/biossíntese , Apoptose/efeitos dos fármacos , Ciclo Celular/efeitos dos fármacos , Morte Celular/efeitos dos fármacos , Linhagem Celular Transformada , Sobrevivência Celular/efeitos dos fármacos , Transformação Celular Viral , Relação Dose-Resposta a Droga , Fase G1/efeitos dos fármacos , Genes Reporter , Humanos , Marcação In Situ das Extremidades Cortadas/métodos , Luciferases/metabolismo , NF-kappa B/antagonistas & inibidores , Plasmídeos , RNA Interferente Pequeno/metabolismo , Fatores de Tempo , Transcrição Gênica/efeitos dos fármacos , TransfecçãoRESUMO
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.
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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.
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Bioensaio/normas , Biomarcadores/análise , Guias como Assunto , Fenômenos Imunogenéticos , Relatório de Pesquisa , United States Food and Drug Administration/legislação & jurisprudência , Humanos , Estados UnidosRESUMO
Initiated as a cable-replacement solution, short-range wireless power transfer has rapidly become ubiquitous in the development of modern high-data throughput networking in centimeter to meter accessibility range. Wireless technology is now penetrating a higher level of system integration for chip-to-chip and on-chip radiofrequency interconnects. However, standard CMOS integrated millimeter-wave antennas have typical size commensurable with the operating wavelength, and are thus an unrealistic solution for downsizing transmitters and receivers to the micrometer and nanometer scale. Herein, we demonstrate a light-in and electrical signal-out, on-chip wireless near-infrared link between a 220 nm optical antenna and a sub-nanometer rectifying antenna converting the transmitted optical energy into direct electrical current. The co-integration of subwavelength optical functional devices with electronic transduction offers a disruptive solution to interface photons and electrons at the nanoscale for on-chip wireless optical interconnects.