• 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.

• Korean Journal of Food Science and Technology
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• v.39 no.4
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• pp.353-359
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• 2007

This survey was carried out to estimate the heavy metal contents of fishes (531 ocean fishes and 80 freshwater fishes) sold in and around Korea from April to October in 2006 . The contents of arsenic (As), cadmium (Cd), copper (Cu), lead (Pb), manganese (Mn), zinc (Zn) and mercury (Hg) were estimated by inductively coupled plasma-mass spectrometry (ICP-MS) and a mercury analyzer. The concentrations [mean (minimum-maximum) mg/kg] of heavy metals in the ocean fishes were as follows: As=2.523 (0.140-65.543), Cd=0.017 (0.000-0.108), Cu=0.569 (0.040-5.634), Pb=0.023 (0.000-0.323), Hg=0.068 (0.002-0.754), Mn=0.395 (0.016-4.651) and Zn=6.086 (0.529-34.729). The concentrations of heavy metals in the freshwater fishes were: As=0.370 (0.024-2.231), Cd=0.01l (ND-0.086), Cu=0.628 (0.003-1.962), Pb=0.026 (ND-0.423), Hg=0.058 (0.006-0.349), Mn=1.150 (0.069-7.230) and Zn=9.980 (3.463-82.737). The weekly intakes of Cd, Hg and Pb from fish were 0.9, 1.6 and 0.9%, respectively, as compared with the Provisional Tolerable Weekly Intake (PTWl) established by Joint FAO/WHO Expert Committee for food safety evaluation.

• International Journal of Stem Cells
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• v.16 no.3
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• pp.281-292
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• 2023

Background and Objectives: Human induced pluripotent stem cell (hiPSC)-derived cardiomyocyte (CM) hold great promise as a cellular source of CM for cardiac function restoration in ischemic heart disease. However, the use of animal-derived xenogeneic substances during the biomanufacturing of hiPSC-CM can induce inadvertent immune responses or chronic inflammation, followed by tumorigenicity. In this study, we aimed to reveal the effects of xenogeneic substances on the functional properties and potential immunogenicity of hiPSC-CM during differentiation, demonstrating the quality and safety of hiPSC-based cell therapy. Methods and Results: We successfully generated hiPSC-CM in the presence and absence of xenogeneic substances (xeno-containing (XC) and xeno-free (XF) conditions, respectively), and compared their characteristics, including the contractile functions and glycan profiles. Compared to XC-hiPSC-CM, XF-hiPSC-CM showed early onset of myocyte contractile beating and maturation, with a high expression of cardiac lineage-specific genes (ACTC1, TNNT2, and RYR2) by using MEA and RT-qPCR. We quantified N-glycolylneuraminic acid (Neu5Gc), a xenogeneic sialic acid, in hiPSC-CM using an indirect enzyme-linked immunosorbent assay and liquid chromatography-multiple reaction monitoring-mass spectrometry. Neu5Gc was incorporated into the glycans of hiPSC-CM during xeno-containing differentiation, whereas it was barely detected in XF-hiPSC-CM. Conclusions: To the best of our knowledge, this is the first study to show that the electrophysiological function and glycan profiles of hiPSC-CM can be affected by the presence of xenogeneic substances during their differentiation and maturation. To ensure quality control and safety in hiPSC-based cell therapy, xenogeneic substances should be excluded from the biomanufacturing process.

• Archives of Pharmacal Research
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• v.6 no.1
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• pp.7-16
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• 1983

A methadone-diazepam interaction study in rats was performed in which conjugated metabolites of methadone were analyzed using deuterated biosynthetic internal standards. Diazepam (5mg/kg) was given to rats through a cannulate djugular vein and a subcutaneous dose of methadone (10mg/kg) was given. Bile was collecte through the cannulate dbile duct over a period of 24 hours. The deuterium label of the internal standards was found to be stable under conditions of the prolonged incubation. There was no significant difference in the excretion of the metabolites between the control and the diazepam treated rats. Feasibility of using biosynthetic internal standards with selected ion monitoring was established for the drug metabolism and kinetic studies.

• Journal of Food Hygiene and Safety
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• v.23 no.3
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• pp.198-205
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• 2008

In this study, microbial investigation is accomplished for 554 Jeot-kal samples(102 of Jeot-kal, 448 of Seasoned Jeot-kal and 4 of Sik-khe, respectively) that corresponds with Coliform-bacteria, Escherichia coli, Aerobic live bacteria as hygienic indicator microorganisms, and Staphylococcus aureus, Vibrio parahaemolyticus as Food-borne pathogenic microorganisms, Based on the methods in Korea Food Code, reliable data are obtained as follows; in 31.9% rate of the samples, Coliform bacteria are verified in the extent of $0{\sim}20,000$ CFU/g as 2.3 logCFU/g. Especially, Seasoned Jeot-kal(37.7%,2.3 logCFU/g) are detected to 6 and 2 folds higher than those of Jeot-kal, 5.9% and 1.4 logCFU/g. Likewise, Escherichia coli is detected from 9 samples only in Seasoned Jeot-kal, that includes seasoned squid, seasoned octopus, seasoned roe of pollack, seasoned large-eyed herring and seasoned hairtail. Aerobic live bacteria are also detected in the range of $0{\sim}8.9{\times}10^8CFU/g$. Against salinity, E. coli are detected in samples only less than 10% salinity. Concomitantly, aerobic live bacteria count is decreased to $5.5{\sim}3.6$ log CFU/g upon the salinity is increased up to 25%. However, S. aureus and V. parahaemolyticus are not detected in 554 samples, presumptively referring Jeot-kal products are somehow free from such food-borne pathogens. As the results above, we deliberately consider that the sanitary control in Jeot-kal, which be necessarily fermented- as well as non-microbially inactivated should be ensured in near future and also suggest an effectual microbial standard corresponding to the Negativity in E. coli for Jeot-kal products.

• Tuberculosis and Respiratory Diseases
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• v.41 no.4
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• pp.405-412
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• 1994

Background: In Korea, the prevalence of tuberculosis and hepatitis is high, and combined therapy with rifampicin and pyrazinamide is used in tuberculosis, so drug induced hepatitis is not only problem of tuberculosis therapy but also cause of treatment failure. However most of recent reports on drug induced hepatitis during antituberculosis medication have dealt with its pathogenesis and have stressed the biochemical, and histopathological aspects of the disorder, whereas this study was designed primarily to provide information on the clinical features. Method: The subjects of study were 1414 patients treated with antituberculosis drugs on the department of chest medicine at National Medical Center during the 5-year 6-month period from January 1, 1988, to June 30, 1993. Retrospective analysis of clinical features for the 29 patients who developed drug induced hepatitis was done. Results: 1) The incidence of antituberculosis drug induced hepatitis was 2.1%. 2) Male to fema1e ratio of antituberculosis drug induced hepatitis was 2:1, but case rates among males and females were not significantly different. 3) Rates of drug induced hepatitis according to age distribution shows the most common incidence between 35 to 49 year old age group, but rates among groups of age were not significant1y different. 4) Drug induced hepatitis was most common in the case of moderate advanced pulmonary tuberculosis(rate is 2.78%), but rates among types of tuberculosis were not significant1y different. 5) 18 cases(62%) of antituberculosis drug induced hepatitis patients had no signs or symptoms. In remaining cases, they were nausea, vomiting, jaundice, hepatomegaly, icteric sclera, right upper quadrant tenderness in order. 6) 22 cases(76%) of antituberculosis drug induced hepatitis cases had occured within the first month. 7) The duration of abnormal liver function was $28{\pm}5$(Mean${\pm}$SD), ranged from 5 days to 180 days. 8) One case of antituberculosis drug induced hepatitis died. 9) The levels of abnormal GOT ranged from 64 to 1055U/L and GPT from 68 to 931U/L. Conclusion: There are no dicided predisposing factors of antituberculosis drug induced hepatitis, so it should be done biochemical monitoring as well as close monitoring for overt signs or symptoms of hepatitis to avoid the development of irreversible hepatic reaction, especially at the treatment of the first month.

• Quality Improvement in Health Care
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• v.1 no.1
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• pp.56-65
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• 1994

Total quality management has been a focus of concern in recent years since some dissatisfaction with the results from implementation of quality assurance programs in the U.S. Many managerial methodologies and innovation guidelines from academic disciplines have been applied to promote TQM programs in the health field. This paper consists of two folds of aspects: firstly to examine TQM's managerial philosophy by comparing with the newly introduced managerial concepts in Business Reengineering; and then to introduce a method for an integrative way of process analysis, Entity Life-Cycle Diagram (ELCD) modeling. The analysis method was compared with Process Map, which is a well-known method for BR applications. To show effectiveness of ELCD modeling, a case of application was introduced using 'drug' as a target entity. With having TQM issues in mind, the result was reflected in designing Entity Relation Diagrams. The results of ELCD modeling turn out to be helpful in designing database related to quality monitoring, in that many monitoring check points can be identified in a systematic way and that queries cross-sectional over organizational boundaries can be generated with a consistent view focusing on the drug use as a single process. Full evaluation of the analysis method remains to be studied until the completion of the information system under construction. But as long as TQM is based on a process-oriented view and needs supports from information system, ELCD can be one of the appropriate choice as a tool for the process analysis.

• YAKHAK HOEJI
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• v.52 no.4
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• pp.288-292
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• 2008

Olanzapine, an atypical antipsychotic, has been widely used for the treatment of schizophrenia and bipolar disease. Although olanzapine is less associated with extrapyramidal symptoms and neuroleptic malignant syndrome compared to existing typical antipsychotics, the use of this drug has a problematic side effect of weight gain, which may cause metabolic syndrome such as type 2 diabetes. However, there are few hospitals practicing body weight monitoring of the patients on olanzapine or other atypical antipsychotics. The goal of this study was to identify the incidence and severity of weight gain associated with the use of the drug in Korea. We performed body weight monitoring of the patients who were on the drug in a hospital setting. Mean of the weight gain (as of one-month-transformation) was 4.33 and 3.39 kg for the male and female patients, respectively. The incidence in the young patients was higher than that observed in the old patients, and the severity was the highest in patients in their thirties followed by twenties or younger. This result suggests that the pattern of the weight gain associated with the use of olanzapine in Korea is similar to the reports performed and documented in US and European countries. Therefore, it appears that healthcare professionals in Korea should also watch on the weight gain issue in patients who are on olanzapine or other atypical antipsychotics.

• The Journal of Korean Academic Society of Nursing Education
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• v.5 no.1
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• pp.39-57
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• 1999

Essential hypertension is a typical chronic disease requiring adequate and continuous management. And many studies supported that self-care was the essential factor to promote the wellbeing. The purpose of this study is to identify and understand the behavior patterns of self-care in hypertensives. As a research method, 35 Q-statements were collected through Individual interviews and review of the related literatures. 21 subjects were interviewed and the data were analyzed by the PC QUANL program with principal component analysis. There were 6 different self-care types classified as follows 1) Type 1 was the self-oriented control type, monitoring the blood pressure and taking the low salt diet. But they didn't take the anti -hypertensive drug and visit the health agency regularly. 2) Type 2 was the stress-control type. Their main activities were meditation to relieve the stress and communication with family. 3) Type 3 was called daily-life control type. This type tried to make their mind comfort and think positively. They also preferred walking and exercise regularly. 4) Type 4 was the medical-oriented control type, taking the anti-hypertensive drug, visiting the medical personnel and following the medical regimens. 5) Type 5 was the medication-oriented type. They only took the anti -hypertensive drug regularly and didn't any other self-care like as monitoring the blood pressure, taking the low salt diet and exercise. 6) Type 6 was called non-medication control type. This type had no medication, but tried to visit the health agency and health personnel. From the above results, it can be concluded that the self-care types were very various and self-care education have to provide individually according to the characteristics of self-care type. Another repeated study can be recommended to improve the nursing intervention the self-care behavior in chronic patient like as diabetics or rheumatoid arthritis.

• Journal of Food Hygiene and Safety
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• v.22 no.1
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• pp.52-56
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• 2007

In order to offer monitoring data about standard and specification of metallic kitchenware, we carried out the material test and migration test of lead and antimony in 71 kinds of kitchenwares. As a result of this study, Pb was detected less than 0.06% at the material test and Sb was not defected in 71 kinds of kitchenwares. Pb was also detected less than 0.41 mg/L at the migration test. Currently according to the Food Code of Korea, Pb and Sb in metal product shall not exceed 10% and 5%, respectively and Pb migrated from metal product shall not exceed 1.0 mg/L. Therefore, our all data are not exceeding the standard and specification of metal product and show that all the kitchenwares in domestic circulation may be safe.