• Title/Summary/Keyword: Reproducibility evaluation

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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.

Evaluation of Gelation Characteristics with The Variation of Additive Contents in The Alumina Slurry for Gel Casting Process (겔 캐스팅 공정을 위한 알루미나 슬러리에서의 첨가제 함량 변화에 따른 겔화특성 평가)

  • Chung, J.K.;Oh, C.Y.;Ha, T.K.
    • Transactions of Materials Processing
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    • v.31 no.5
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    • pp.290-295
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    • 2022
  • Recently, the use of high-tech ceramic parts in functional electronic parts, automobile parts and semiconductor equipment parts is increasing. These ceramics materials are required to have high reproducibility, reliability, large size and complex shapes. The researchers initiated the work to develop a new shaping method called gel casting, which allows high performance ceramic materials with a complex shape to be produced. The manufacturing process parameters of gel casting include uniform mixing of the initiator, bubble removal, and slip injection. In this study, we analyzed the dispersion and gelation characteristics according to the change in the additive content of the alumina slurry in the gel casting process. The alumina slurry for gel casting was prepared by mixing a solvent, a monomer and a dispersant through a ball mill. Alumina powder and a gelation initiator were added to the mixed solution, and ball milling was performed for 24 hours. A viscosity of 6,435 cps and a stable zeta potential value were obtained under the conditions of alumina powder content of 55 vol% and dispersant 2.0 wt%. After curing for 12 hours by adding aps 0.1wt%, TEMED 0.2wt%, and Monomer 3, 5wt%, it was possible to separate from the molding cup, confirming that the gelation was completed.

Validation and measurement uncertainty of HPLC method for simultaneous determination of 10 dyes in adulterated Phellodendron

  • Lim, Suji;Yun, Choong-In;Ko, Kyung Yuk;Kim, Young-Jun
    • Korean Journal of Food Science and Technology
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    • v.53 no.4
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    • pp.391-398
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    • 2021
  • As global interest in herbal medicines has increased, the adulteration of herbal medicines has become a critical safety issue. Adulteration with dyes to improve the appearance of low-quality products is of particular concern. This study aimed to develop a high-performance liquid chromatography (HPLC) method to detect dyes added as adulterants to Phellodendron. Samples were analyzed on a C18 column using 50 mM ammonium acetate and acetonitrile as the mobile phase. All calibration curves showed good linearity (r2 ≥0.9999) over the five-point concentration range (1-50 mg/kg). Limit of detection ranged from 0.04-0.35 mg/kg, and limit of quantification ranged from 0.11-1.07 mg/kg. The repeatability and reproducibility for these measurements were 94.2-103.3% and 96.6-103.8% for accuracy and 0.14-2.28 RSD (%) and 0.80-2.37 RSD (%) for precision. Moreover, the measurement uncertainty of the low, medium, and high concentrations for 10 dyes was considered. Thus, this HPLC method is suitable for detecting color adulteration of Phellodendron.

Evaluation of minimally invasive surgical reduction of sacroiliac luxation in toy breed dogs: a cadaver study

  • Ahn, Seoung-Yob;Jeong, Soon-Wuk
    • Journal of Veterinary Science
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    • v.23 no.2
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    • pp.38.1-38.13
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    • 2022
  • Background: Minimally invasive surgery (MIS) technique of sacroiliac luxation in toy breed dogs using cannulated screws has not been described. Objectives: The purpose of this study was to evaluate the effectiveness of pelvic canal recovery, the reproducibility of successful surgery outcomes, and the acceptable difficulty of the procedure in MIS of sacroiliac luxation in toy breed dogs. Methods: MIS using 2.3-mm cannulated screws was demonstrated in 12 toy breed dog cadavers with sacroiliac luxation artificially induced. Pre and postoperative radiographs were used to evaluate the pelvic canal diameter ratio (PCDR), hemipelvic canal width ratio (HCWR), and reduction rate. Dorsoventral angle (DVA) and craniocaudal angle (CCA) of the inserted screw were obtained postoperative computed tomographic scan. Results: The statistically significant difference between the mean pre and postoperative PCDR was found (1.10 ± 0.12 and 1.26 ± 0.11, respectively; p = 0.002), and the mean HCWR close to 1.0 meaning symmetric pelvis also was obtained (0.97 ± 0.07). The mean DVA and CCA were 2.26° ± 1.33° and 2.60° ± 1.86°, respectively. Conclusions: MIS of sacroiliac luxation using 2.3-mm cannulated screws is applicable to toy breed dogs with acceptable difficulty.

Application of Artificial Intelligence-based Digital Pathology in Biomedical Research

  • Jin Seok Kang
    • Biomedical Science Letters
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    • v.29 no.2
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    • pp.53-57
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    • 2023
  • The main objective of pathologists is to achieve accurate lesion diagnoses, which has become increasingly challenging due to the growing number of pathological slides that need to be examined. However, using digital technology has made it easier to complete this task compared to older methods. Digital pathology is a specialized field that manages data from digitized specimen slides, utilizing image processing technology to automate and improve analysis. It aims to enhance the precision, reproducibility, and standardization of pathology-based researches, preclinical, and clinical trials through the sophisticated techniques it employs. The advent of whole slide imaging (WSI) technology is revolutionizing the pathology field by replacing glass slides as the primary method of pathology evaluation. Image processing technology that utilizes WSI is being implemented to automate and enhance analysis. Artificial intelligence (AI) algorithms are being developed to assist pathologic diagnosis and detection and segmentation of specific objects. Application of AI-based digital pathology in biomedical researches is classified into four areas: diagnosis and rapid peer review, quantification, prognosis prediction, and education. AI-based digital pathology can result in a higher accuracy rate for lesion diagnosis than using either a pathologist or AI alone. Combining AI with pathologists can enhance and standardize pathology-based investigations, reducing the time and cost required for pathologists to screen tissue slides for abnormalities. And AI-based digital pathology can identify and quantify structures in tissues. Lastly, it can help predict and monitor disease progression and response to therapy, contributing to personalized medicine.

A Study on the Evaluation of Concrete Unit-Water Content of FDR Sensor Using Deep Learning and Machine Learning (딥러닝과 머신러닝을 이용한 FDR 센서의 콘크리트 단위수량 평가에 관한 연구)

  • Lee, Seung-Yeop;Youn, Ji-Won;Wi, Gwang-Woo;Yang, Hyun-Min;Lee, Han-Seung
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2022.11a
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    • pp.29-30
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    • 2022
  • The unit-water content has a very significant effect on the durability of the construction structure and the quality of concrete. Although there are various methods for measuring the unit-water content, there are problems of time required for measurement, precision, and reproducibility. Recently, there is an FDR sensor capable of measuring moisture content in real time through an apparent dielectric constant change of electromagnetic waves. In addition, various artificial intelligence techniques that can non-linearly supplement the accuracy of FDR sensors are being studied. In this study, the accuracy of unit-water content measurement was compared and evaluated using machine learning and deep learning techniques after normalizing the data secured in concrete using frequency domain reflectometry (FDR) sensors used to measure soil moisture at home and abroad. The result of comparing the accuracy of machine learning and deep learning is judged to be excellent in the accuracy of deep learning, which can well express the nonlinear relationship between FDR sensor data and concrete unit-water content.

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Development and Evaluation of Integrated Management Program for Hemodialysis Patients (혈액투석 환자를 위한 통합적 관리 프로그램의 개발 및 효과)

  • Kim, Bora;Yoo, Hana
    • Journal of Korean Academic Society of Home Health Care Nursing
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    • v.31 no.1
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    • pp.66-76
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    • 2024
  • Purpose: This study aimed to develop and evaluate an integrated management program to enhance self-efficacy, compliance with sick-role behaviors, symptom management, and biomarker indication in hemodialysis patients. Methods: The integrated management program was developed through a systematic review of literature, analysis of relevant online data, and expert validation. It comprised 480 min of video-based education delivered eight times over four weeks, supplemented by weekly phone consultations and text message support from a nurse. To evaluate the program's effectiveness, it was administered to 44 patients with hemodialysis in a single group in a pre-post test experimental study. Changes in self-efficacy, sick-role behavior compliance, dialysis symptom index, and biomarkers were assessed. Results: The program yielded statistically significant improvements in self-efficacy (t=-7.13, p<.001), sick-role behavioral compliance (t=-7.35, p<.001), dialysis symptom index (t=4.32, p<.001), and blood urea nitrogen levels (t=2.55, p=.014) among the participants. Conclusion: The integrated management program is an effective intervention for improving hemodialysis patients' self-efficacy, compliance with sick-role behaviors, and experience of symptoms. Additionally, it is considered an intervention with high clinical applicability and efficiency through video reproducibility.

Optimization of Ceramide Analysis Method Using LC-MS in Cosmetics

  • Su-Jin Park;Hee-Jin Yoo;Duck-Hyun Kim;Ji-Won Park;Eunji Jeon;Abhik Mojumdar;Kun Cho
    • Mass Spectrometry Letters
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    • v.15 no.1
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    • pp.49-53
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    • 2024
  • Ceramide is a lipid in which sphingoid bases and fatty acids are linked by amide bonds. As a marker of skin disease in the human stratum corneum, its disease-causing and therapeutic effects have been partially confirmed, and it is therefore an important element in commercially available cosmetic formulations. However, structural diversity caused by differences in the chain length, number, and location of hydroxyl groups makes quality control difficult. In this study, a method was established to separate different ceramide species using reversed-phase LC-MS/MS and thus enable qualitative evaluation. Separation of four standards was achieved within a short retention time, and the accuracy and sensitivity of the method were demonstrated by the low limit of detection (LOD) calculated based on the calibration curve showing linearity, with R2 > 0.994. After verification of reproducibility and reliability through intra- and inter-day analyses, the efficiency of the method was confirmed through analysis of commercial cosmetic raw materials.

Evaluation of Sperm Fertilizing Capacity Using Acrobeads Test (Acrobeads Test를 이용한 정자수정능의 평가)

  • Park, Young-Soo;Park, Nam-Cheol
    • Clinical and Experimental Reproductive Medicine
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    • v.23 no.1
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    • pp.81-86
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    • 1996
  • The assessment of acrosomal status is important in evaluating the ability of sperm to fertilize the egg. The acrosomal status of sperm from 47 normal volunteers with proven fertility and 167 subfertile men with not to achieve pregnancy for at least 1 year were evaluated with Acrobeads test(FUSO Pharmaceutical Industries, Ltd, Japan) using immunobeads coated with MH61 monoclonal antibody, which is specific for acrosome-reacted sperm. The mean${\pm}$SD of acrobeads score in 47 volunteer group was $2.8{\pm}0.7$, of which 46(97.9%)cases were ${\geq}$ 2. The mean${\pm}$SD of acrobeads score in 167 subfertile group was $1.7{\pm}0.8$, of which 73(79.3%)cases were ${\leq}$ 1. The aerobe ads score in subfertile group were significantly lower(r=0.294, p<0.05) than those in volunteer group. In subfertile group, acrobeads score were well correlated with the sperm density and motility(r=0.275, r=0.281, p<0.01), but not with semen volume(r=0.16) and serum hormone level(FSH r=0.084, LH r=0.036, testosterone r=0.058, prolactin r=0.006 and estradiol r=0.060)(p>0.05). Of 63 subfertile cases with normozoospermia, 22(34.9%)cases showed 0 or 1 of acrobeads score, which means to accompany with a functional defect in spite of normal morphology. As a results, Acrobeads test is not only a technically simple sensitive procedure with good reproducibility in evaluating the sperm fertilizing capacity but also an useful in the evaluation of effectiveness in the treatment of infertility and the separation of acrosome-reacted sperm in the assisted reproductive technique.

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Revaluation of Reflux Finding Score(RFS) in Laryngopharyngeal Reflux(LPR) (인후두역류증의 진단에 있어서 후두내시경검사 소견 점수화의 유용성에 대한 재검증)

  • Kwon, Kee-Hwan;Ban, Jae-Ho;Lee, Kyung-Chul
    • Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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    • v.15 no.2
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    • pp.81-86
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    • 2004
  • Background and Objectives : In general, ambulatory 24-hour pH monitoring is considered the current gold standard for larynogopharyngeal reflux(LPR). There is no validated instrument whose purpose is to document the physical finding and severity of laryngopharyngeal reflux. The purposes of this study are to revaluate the validity and reliability of the reflux finding score(RFS) and to quantify laryngoscopic findings using reflux finding score. Material and Methods : Thirty-three LPR patients confirmed by dual-probe pH monitoring and thirty patients of control were selected. The RFS was documented for each patient with telescopic laryngoscopy before treatment. For test-retest intraobserver reliability assessment, a blinded laryngologists determined the RFS on two separate occasions. To evaluate interobserver reliability assessment, the RFS was determined by t재 different blinded laryngologists. Results : The mean age of the cohort with pH-documented LPR was 45.8 years and the mean RFS was 11.4. The mean age of cotrol subjects was 52 years and the mean RFS was 5.4. The mean RFS for laryngologist no. 1 was 10.8 at the initial screening and 10.9 at the repeat evaluation. The mean FRS for laryngologist no.2 was 11.1 at the intial test and 10.9 at the repeat evaluation. The correlation coefficient for interobserver variability was 0.93 and intraobserver variability was 0.94. Conclusion : The RFS demonstrates excellent inter-and introaobserver reproducibility and is helpful for quantifying laryngeal finding in LPR. We can be 95% certain that an individual with a RFS greater than 7 has LPR.

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