• Title/Summary/Keyword: Safety evaluation Platform

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Facile and Rapid Glycosylation Monitoring of Therapeutic Antibodies Through Intact Protein Analysis

  • Oh, Myung Jin;Seo, Nari;Seo, JungA;Kim, Ga Hyeon;An, Hyun Joo
    • Mass Spectrometry Letters
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    • v.12 no.3
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    • pp.85-92
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    • 2021
  • The therapeutic antibody drug market has experienced explosive growth as mAbs become the main therapeutic modality for a variety of diseases. Characterization of glycosylation that directly affects the efficacy and safety of therapeutic monoclonal antibodies (mAbs) is critical for therapeutics development, bioprocess system optimization, lot release, and comparability evaluation. The LC/MS approach has been widely used to structurally characterize mAbs, and recently attempts have been made to obtain comprehensive information on the primary structure and post-translational modifications (PTMs) of mAbs through intact protein analysis. In this study, we performed state-of-the-art LC/MS based intact protein analysis to readily identify and characterize glycoforms of various mAbs. Different glycoforms of mAbs produced in different expression cell lines including CHO, SP2/0 and HEK cells were monitored and compared. In addition, the comparability of protein molecular weight, glycoform pattern, and relative abundances of glycoforms between the commercialized trastuzumab biosimilar and the original product was determined in detail using the given platform. Intact mAb analysis allowed us to gain insight into the overall mAb structure, including the complexity and diversity of glycosylation. Furthermore, our analytical platform with high reproducibility is expected to be widely used for biopharmaceutical characterization required at all stages of drug development and manufacturing.

The Effect of the Fault Tolerant Capability due to Degradation of the Self-diagnostics Function in the Safety Critical System for Nuclear Power Plants (원자력발전소 안전필수시스템 고장허용능력에 대한 자가진단기능 저하 영향 분석)

  • Hur, Seop;Hwang, In-Koo;Lee, Dong-Young;Choi, Heon-Ho;Kim, Yang-Mo;Lee, Sang-Jeong
    • The Transactions of The Korean Institute of Electrical Engineers
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    • v.59 no.8
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    • pp.1456-1463
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    • 2010
  • The safety critical systems in nuclear power plants should be designed to have a high level of fault tolerant capability because those systems are used for protection or mitigation of the postulated accidents of nuclear reactor. Due to increasing of the system complexity of the digital based system in nuclear fields, the reliability of the digital based systems without an auto-test or a self-diagnostic feature is generally lower than those of analog system. To overcome this problem, additional redundant architectures in each redundant channel and self-diagnostic features are commonly integrated into the digital safety systems. The self diagnostic function is a key factor for increasing fault tolerant capabilities in the digital based safety system. This paper presents an availability and safety evaluation model to analyze the effect to the system's fault tolerant capabilities depending on self-diagnostic features when the loss or erroneous behaviors of self-diagnostic function are expected to occur. The analysis result of the proposed model on the several modules of a safety platform shows that the improvement effect on unavailability of each module has generally become smaller than the result of usage of conventional models and the unavailability itself has changed significantly depending on the characteristics of failures or errors of self-diagnostic function.

Biofilm Formation and Low pH Viability of Cronobacter spp. (Enterobacter sakazakii) Isolated from Powdered Infant Formula and Infant Foods in Korea (국내 분유 및 영.유아식품에서 분리된 Cronobacter spp. (Enterobacter sakazakii)의 Biofilm 생성 특성 및 내산성 비교)

  • Kim, Sun-Ae;Lee, Yu-Mi;Oh, Se-Wook;Gwak, Hyo-Sun;Hwang, In-Gyun;Kang, Dong-Hyun;Woo, Gun-Jo;Rhee, Min-Suk
    • Food Science of Animal Resources
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    • v.29 no.6
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    • pp.702-708
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    • 2009
  • We investigated biofilm formation in various media, growth in low pH, and the hemolytic activity of 14 strains of Cronobacter spp. (Enterobacter sakazakii) isolated from a variety of foods including powdered infant formula (n=75), infant cereal (n=100), honey (n=30), and other infant foods (n=100) in Korea. The Cronobacter spp. adhered and formed biofilms on polyethylene, and a greater extent of biofilm was observed in nutrient-rich media. No clear difference in biofilm-forming ability was noted among the media constituents and the pattern of biofilm formation was strain-dependent. Seven strains out of 14 strains (50%) grew at pH 4.1, indicating that the acid resistance of these Cronobacter spp. isolated in Korea was relatively low. Hemolytic activity was not observed in any of the strains. This study provides basic information for the physiological and biochemical characteristics of Cronobacter spp. isolated from a variety of infant foods in Korea.

Structural Capacity Evaluation of System Scaffolding using X-Type Advanced Guardrail (교차가새형 선행 안전난간을 적용한 시스템비계의 구조 성능 평가)

  • Park, J.D.;Lee, H.S.;Shin, W.S.;Kwon, Y.J.;Park, S.E.;Yang, S.S.;Jung, K.
    • Journal of the Korean Society of Safety
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    • v.35 no.5
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    • pp.49-58
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    • 2020
  • In domestic construction sites, when installing steel pipe scaffolding and system scaffolding, the guardrails are installed after the installation of the work platforms. This conventional guardrail system (CGS) is always exposed to the risk of falls because the safety railing is installed later. In order to prevent fall disasters during erecting and dismantling scaffolds, it is necessary to introduce the advanced guardrail system (AGS) which installs railings in advance of climbing onto a work platform. For the introduction of the AGS, the structural performance of the system scaffolding applying the CGS and the AGS was compared and evaluated. The structural analysis of the system scaffold (height: 31 m and width: 27.4 m) with AGS confirmed that structural safety was ensured because the maximum stress of each element of the system scaffolding satisfies the allowable stress of each element. As a result of performance comparison of CGS and AGS for each element, the combined stress ratio of vertical posts in AGS was 6.4% lower than that of CGS. In addition, in the case of ledger and transom, the combined stress ratios of AGS and CGS were almost the same. The compression test of the assembled system scaffolding (three-storied, 1 bay) showed that the AGS had better performance than the CGS by 9.7% (8.91 kN). The cross bracing exceeds the limit on slenderness ratio of codes for structural steel design. But the safety factor for the compressive load of the cross bracing was evaluated as meeting the design criteria by securing 3 or more. In actual experiments, it was confirmed that brace buckling did not occur even though the overall scaffold was buckled. Therefore, in the case of temporary structures, it was proposed to revise the standards for limiting on slenderness ratio of secondary or auxiliary elements to recommendations. This study can be used as basic data for the introduction of AGS for installing guardrails in advance at domestic construction sites.

Analysis of Real Ship Operation Data using a Smart Ship Platform (스마트선박 플랫폼을 활용한 실운항 데이터 분석 연구)

  • Kang, Jin-Hui;Lee, Hyun-Ho;Lee, Won-Ju;Lee, In-Ho;Kim, Jae-Woo;Park, Cheong-Hee
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.25 no.6
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    • pp.649-657
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    • 2019
  • An essential part of the development of an autonomous ship is supporting technology that can effectively check and diagnose the operational status of the ship form the shore control center on land. This development has recently occurred in the shipbuilding and shipping industries. In this paper, we present a smart ship solution that operates, as a single system, a data collection platform that gathers ship operation data and a service platform that provides various services. When this smart ship solution was applied to an operating ship, it was determined that a variety of high-quality data could be collected compared to existing ship data collection systems. In addition, it was shown that of the operation data collected, analysis of parameters related to the main engine can be used to determine the overall state by deriving valid results and visualizing patterns. In conclusion, it was suggested that a ship's operation status could be checked more effectively and a comprehensive evaluation could be possible at the shore control center if the results of this study were extended to various ship equipment and analyzed together with the operational environment data.

Developing VR-based Sailor Training Platform Authoring Tool (가상현실 기반 선원 훈련 플랫폼 저작도구 개발)

  • Jung, Jinki;Lee, Hyeopwoo
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 2016.05a
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    • pp.181-185
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    • 2016
  • In this paper we propose a VR-based Sailor Training Platform Authoring Tool which efficiently trains sailors in immersive ways. Proposed authoring tool consists of virtual environment reconstruction that imports real ship indoor environment into virtual environment and script editing which is able to implement various scenarios in emergency based on just drag-and-drop interface. The aim of importing real ship environment and supporting various VR devices is to enhance immersiveness and training so that trainees can deal with serious emergency events. Also the usefulness of the interface enables to reduce the cost of making training materials. Throughout scenario editing interface, the proposed authoring tool supports the editing of multi-user scenario and setting individual task for the evaluation.

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Development of a Cardiac Catheter Remote Control Robot Platform for Radiofrequency Ablation Intervention (고주파 절제술을 위한 심장전극도자 원격 제어 로봇 플랫폼의 개발)

  • Park, Jun-Woo;Song, Seung-Joon;Lee, Jung-Chan;Choi, Hyuk;Lee, Jung-Joo;Choi, Jae-Soon
    • The Transactions of The Korean Institute of Electrical Engineers
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    • v.60 no.7
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    • pp.1417-1426
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    • 2011
  • Radiofrequency ablation through cardiac catheterization is one of minimally invasive intervention procedures used in drug resistant arrhythmia treatment. To facilitate more accurate and precise catheter navigation, systems for robotic cardiac catheter navigation have been developed and commercialized. The authors have been developing a novel robotic catheter navigation system. The system is a network-based master-slave configuration 3-DOF (Degree-Of-Freedom) robotic manipulator for operation with conventional cardiac ablation catheter. The catheter manipulation motion is composed of the translation (forward/backward) and the roll movements of the catheter and knob rotation for the catheter tip articulation. The master manipulator comprises an operator handle compartment for the knob and the roll movement input, and a base platform for the translation movement input. The slave manipulator implements a robotic catheter platform in which conventional cardiac catheter is mounted and the 3-DOF motions of the catheter are controlled. The system software that runs on a realtime OS based PC, implements the master-slave motion synchronization control in the robot system. The master-slave motion synchronization performance tested with step, sinusoidal and arbitrarily varying motion commands showed satisfactory results with acceptable level of steady state error. The developed system will be further improved through evaluation of safety and performance in in vitro and in vivo tests.

The Study of System Visibility of Universal Middleware Pervasive Memorial Engine (시스템가시성평가를 위한 유니버설미들웨어기반 Pervasive Memorial Engine 연구)

  • Lee, Hae-Jun;Hwang, Chi-Gon;Yoon, Chang-Pyo
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2017.10a
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    • pp.335-338
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    • 2017
  • Presently, the collaboration hardware system and software technology that promoted commercializing ICBMS for integrated system visibility evaluation. This variation will move on the next pervasive period that mixed with cultural and technology convergence. There is possibility for the period system can invoke unpredictable confusing blank state. The blank state systems have ecosystem characteristics that are supplied, maintained and operated through the complex interactions of technology and culture. Using universal middleware can support the life-cycle model and increase the visibility of complex systems and prepare for confusing situations. In this study, based on universal middleware, data and service dynamic standardized modules were evaluated to support stable system visibility platform. The system visibility module consists of Intelligent Pervasive Cloud module, Memorial Service module and Life Cycler connection module. each module reflects various requirements of system visibility requested by external system. In addition, the analysis results are supported by various network application service standards through platform independent system and architecture.

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Work-Related Stress Risk Assessment in Italy: A Methodological Proposal Adapted to Regulatory Guidelines

  • Persechino, Benedetta;Valenti, Antonio;Ronchetti, Matteo;Rondinone, Bruna Maria;Tecco, Cristina Di;Vitali, Sara;Iavicoli, Sergio
    • Safety and Health at Work
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    • v.4 no.2
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    • pp.95-99
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    • 2013
  • Background: Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. Methods: After close analysis of the Italian and European reference regulatory framework and workrelated stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. Results: We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. Conclusion: This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

Framework for Car Safety Education Virtual Reality Simulation (자동차 안전교육 VR 시뮬레이션 제작을 위한 프레임워크)

  • Xie, Qiao;Ding, Xiu Hui;Jang, Young-Jick;Yun, Tae-Soo
    • Journal of the Korea Convergence Society
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    • v.10 no.9
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    • pp.37-45
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    • 2019
  • In recent years, the emergence of virtual reality (VR Virtual Reality) technology has provided a new model of safety education, enabling users to learn and respond to disasters in a virtual safety education environment. However, the related VR products related to domestic and foreign R & D are relatively simple, there is no practical training on specific accident, and it is not practical enough to play a sufficient role in safety education. In this paper, the problems and disadvantages of VR technology applied in the field of automobile safety education as an example of automobile accident among the types of disasters are examined, and a system framework of automotive safety education based on VR technology is proposed. The vehicle safety education system proposed in this paper will help users to improve driving safety consciousness, to acquire safety knowledge in driving, and to acquire driving safety skill which is very important for automobile safety education. In addition, the design and production methods of safety education based on VR technology are considered to have important reference implications for the application of modern teaching and teaching theory by integrating with VR technology and developing related teaching materials products and finally introducing education.