• Title/Summary/Keyword: Biologics

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Prediction Model for the Cellular Immortalization and Transformation Potentials of Cell Substrates

  • Lee, Min-Su;Matthews Clayton A.;Chae Min-Ju;Choi, Jung-Yun;Sohn Yeo-Won;Kim, Min-Jung;Lee, Su-Jae;Park, Woong-Yang
    • Genomics & Informatics
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    • v.4 no.4
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    • pp.161-166
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    • 2006
  • The establishment of DNA microarray technology has enabled high-throughput analysis and molecular profiling of various types of cancers. By using the gene expression data from microarray analysis we are able to investigate diagnostic applications at the molecular level. The most important step in the application of microarray technology to cancer diagnostics is the selection of specific markers from gene expression profiles. In order to select markers of Immortalization and transformation we used c-myc and $H-ras^{V12}$ oncogene-transfected NIH3T3 cells as our model system. We have identified 8751 differentially expressed genes in the immortalization/transformation model by multivariate permutation F-test (95% confidence, FDR<0.01). Using the support vector machine algorithm, we selected 13 discriminative genes which could be used to predict immortalization and transformation with perfect accuracy. We assayed $H-ras^{V12}$-transfected 'transformed' cells to validate our immortalization/transformation dassification system. The selected molecular markers generated valuable additional information for tumor diagnosis, prognosis and therapy development.

Modulation of Immune Response Induced by Co-Administration of DNA Vaccine Encoding HBV Surface Antigen and HCV Envelope Antigen in BALB/c Mice

  • Nam, Sang-Hyun;Park, Jae-Hyun;Kang, Ju-Hye;Kang, Seog-Youn;Kim, Jae-Hong;Kim, So-Young;Ahn, Joon-Ik;Park, Ki-Sook;Chung, Hye-Joo
    • Archives of Pharmacal Research
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    • v.29 no.11
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    • pp.1042-1048
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    • 2006
  • Plasmid DNA vaccines encoding the hepatitis B virus (HBV) surface and hepatitis C virus (HCV) envelope antigens, respectively, were constructed, and attempt were made to find the possibility of a divalent vaccine against HBV and HCV. The expression of each plasmid in Cos-1 cells was confirmed using immunocytochemistry. To measure the induced immune response by these plasmids in vivo, female BALB/c mice were immunized intramuscularly with $100\;{\mu}g$ of either both or just one of the plasmids. Anti-HBV and HCV-specific antibodies and related cytokines were evaluated to investigate the generation of both humoral and cellular immune responses. As a result, specific anti-HBV and anti-HCV serum antibodies from mice immunized with these plasmids were observed using immunoblot. The levels of IL-2 and RANTES showing a $Th_{1}$ immune response were significantly increased, but there was no change in the level of IL-4 ($Th_{1}$ immune response) in any of the immunized groups. Compared with each plasmid DNA vaccine, the combined vaccine elicited similar immune responses in both humoral and cell-mediated immunities. These results suggest that the combined DNA vaccine can induce not only comparable immunity experimentally without antigenic interference, but also humoral and $Th_{1}$ dominant cellular immune responses. Therefore, they could serve as candidates for a simultaneous bivalent vaccine against HBV and HCV infections.

Current Status and Trends in Inflammatory Bowel Disease Surgery in Korea: Analysis of Data in a Nationwide Registry

  • Baek, Se-Jin;Lee, Kil Yeon;Song, Ki Hwan;Yu, Chang Sik
    • Annals of Coloproctology
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    • v.34 no.6
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    • pp.299-305
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    • 2018
  • Purpose: Inflammatory bowel disease (IBD) in Korea has been increasing in recent years, but accurate statistics about operations for IBD are lacking. The purpose of this study was to investigate the trends and current status of IBD surgeries in Korea. Methods: Using a national database from the Korea Health Insurance Review and Assessment Service, we analyzed data from patients who underwent surgery for Crohn disease and ulcerative colitis from January 2009 to October 2016. Results: The mean number of patients who underwent surgery for Crohn disease was 791.8 per year. Colorectal surgery, small bowel surgery, and anal surgery were performed fairly often (31.2%, 29.4%, 39.4%, respectively), and laparoscopic surgery continued to increase, recently exceeding 30%. About 50% of Crohn patients used biologics before and after surgery, and those patients also underwent a relatively high rate of anal surgeries (44.2%). The mean number of patients who underwent surgery for ulcerative colitis was 247.6 per year. Colorectal surgery accounted for more than half of all operations, and laparoscopic surgery has been increasing rapidly, having been performed in about 60% of patients in recent years. The incidence of colorectal cancer in patients with ulcerative colitis was very high and increased rapidly during the study period, reaching about 80%. Conclusion: The number of patients undergoing laparoscopic surgery for IBD in Korea has increased significantly. Biologics are actively used by patients with Crohn disease, with a high proportion of anal surgeries required. Many of the surgical indications for ulcerative colitis have shifted into colorectal cancer.

Physical and Biochemical Mechanisms Associated with Beef Carcass Vascular Rinsing Effects on Meat Quality: A Review

  • Hwang, Koeun;Claus, James R.;Jeong, Jong Youn;Hwang, Young-Hwa;Joo, Seon-Tea
    • Food Science of Animal Resources
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    • v.42 no.3
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    • pp.389-397
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    • 2022
  • Carcass vascular rinsing and chilling involves infusing a chilled isotonic solution (98.5% water and a blend of mono- and di-saccharides and phosphates) into the vasculature immediately upon exsanguination. Primary purposes of carcass vascular rinsing are to (1) effectively remove residual blood from the carcass; (2) lower internal muscle temperature rapidly; and (3) optimize pH decline by effective delivery of glycolytic substrates in the rinse solution. Previous studies have revealed that the beef carcass vascular rinsing early postmortem positively affects meat quality, product shelflife, and food safety. Thus, the objective of this review is to provide a more comprehensive understanding of the physical and biochemical mechanisms associated with beef carcass vascular rinsing, focusing on the relationship between quality attributes (CIE L*, a*, b*; chemical states of myoglobin; oxygen consumption and sarcomere length) and muscle metabolic response to various substrate solutions (Rinse & Chill®, fructose, sodium phosphate, and dipotassium phosphate) that stimulate or inhibit the rate of glycolysis early postmortem. In addition, this review discusses the absence of metabolite residues (phosphorus, sodium, and glucose) related to the application of the chilled isotonic solution. This review primarily focuses on beef and as such extending the understanding of the mechanisms and meat quality effects discussed to other species associated with vascular rinsing, in particular pork, may be limited.

Vascular rinsing and chilling carcasses improves meat quality and food safety: a review

  • Koeun, Hwang;James R., Claus;Jong Youn, Jeong;Young-Hwa, Hwang;Seon-Tea, Joo
    • Journal of Animal Science and Technology
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    • v.64 no.3
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    • pp.397-408
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    • 2022
  • Rinse & Chill® technology (RCT) entails rinsing the vasculature using a chilled isotonic solution (3℃; 98.5% water and a blend of dextrose, maltose, and sodium phosphates) to rinse out the residual blood from the carcass. Infusion of pre-chilled solutions into intact animal carcasses immediately upon exsanguination is advantageous in terms of lowering the internal muscle temperature and accelerating chilling. This technology is primarily used for purposes of effective blood removal, favorable pH decline, and efficient carcass chilling, all of which improve meat quality and safety. Although RCT solution contains some substrates, the pre-rigor muscle is still physiologically active at the time of early postmortem and vascular rinsing. Consequently, these substrates are fully metabolized by the muscle, leaving no detectable residues in meat. The technology has been commercially approved and in continuous use since 2000 in the United States and since 1997 in Australia. As of January 2022, 23 plants have implemented RCT among the 5 countries (Australia, US, Canada, New Zealand, and Japan) that have evaluated and approved RCT. All plants are operating under sound Sanitation Standard Operation Procedures (SSOP) and a sound Hazard Analysis Critical Control Point (HACCP) program. No food safety issues have been reported associated with the use of this technology. RCT has been adapted by the meat industry to improve product safety and meat quality while improving economic performance. Therefore, this review summarizes highlights of how RCT technically works on a variety of animal types (beef, bison, pork, and lamb).

Assessment of acute inhalation toxicity of citric acid and sodium hypochlorite in rats

  • Jinhee Kim;Chul-Min Park;Su Hyun Choi;Mi Jin Yang;Ju-Yeon Lee;Byung-Suk Jeon;Hyun-Ok Ku;Min-Seok Kim
    • Journal of Veterinary Science
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    • v.24 no.2
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    • pp.22.1-22.12
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    • 2023
  • Background: Citric acid (CA) and sodium hypochlorite (NaOCl) have been used to disinfect animals to protect them against avian influenza and foot-and-mouth disease. Objectives: We performed a good laboratory practice (GLP)-compliant animal toxicity study to assess the acute toxic effects of CA and NaOCl aerosol exposure in Sprague-Dawley rats. Methods: Groups of five rats per sex were exposed for 4 h to four concentrations of the two chemicals, i.e., 0.00, 0.22, 0.67, and 2.00 mg/L, using a nose-only exposure. After a single exposure to the chemicals, clinical signs, body weight, and mortality was observed during the observation period. On day 15, an autopsy, and then gross findings, and histopathological analysis were performed. Results: After exposure to CA and NaOCl, body weight loss was observed but recovered. Two males died in the CA 2.00 mg/L group and, two males and one female died in the 2.00 mg/L NaOCl group. In the gross findings and histopathological analysis, discoloration of the lungs was observed in the CA exposed group and inflammatory lesions with discoloration of the lungs were observed in the NaOCl exposed group. These results suggest that the lethal concentration 50 (LC50) of CA is 1.73390 mg/L for males and > 1.70 mg/L for females. For NaOCl, the LC50 was 2.22222 mg/L for males and 2.39456 mg/L for females. Conclusions: The Globally Harmonized System is category 4 for both CA and NaOCl. In this study, the LC50 results were obtained through a GLP-based acute inhalation toxicity assessment. These results provide useful data to reset safety standards for CA and NaOCl use.

Incidence of Low Seroimmunity to Hepatitis B Virus in Children with Inflammatory Bowel Disease: A Single Center Experience

  • Hala H. Mansour ;Ayman E. Eskander;Sara M. Osman;Normeen H. Rady
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.2
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    • pp.104-112
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    • 2024
  • Purpose: Immunosuppressive therapy is frequently administered to patients with inflammatory bowel disease (IBD), which may make them more susceptible to infections like hepatitis B. Methods: A cross-sectional study was conducted on patients aged 5-18 years diagnosed with IBD who visited a gastroenterology clinic along with controls who were the same age as the patients with IBD and were healthy overall. A logistic regression analysis using the independent variables of age, sex, race, disease phenotype, surgery, and medications and the dependent variable of adequate hepatitis B surface antibody (HBsAb) titers (>10 mIU/mL) was performed on quantitative serum HBsAb titers. Results: The study enrolled 62 patients, including 37 males and 25 females. Crohn's disease, ulcerative colitis, and indeterminate colitis were diagnosed in 16, 22, and 24 patients, respectively. Thirty-nine patients were taking corticosteroids at the time of the study, 42 were taking immunomodulators, and four were taking biologics. Compared to 44.7% of the control group, 9.3% of the patients had protective titers. Only 12 out of 62 patients had HBsAb titers greater than 10 million IU/mL. None of the patients who received biologics or corticosteroids and 3.2% of those who received immunomodulators were found to be seroimmuned. Conclusion: The younger patients had the highest titers. Patient-specific factors that may impact these low titers include the length of the patient's illness and the use of immunosuppressants.

Statistical Assessment of Biosimilarity based on the Relative Distance between Follow-on Biologics in the (k + 1)-Arm Parallel Design

  • Kang, Seung-Ho;Shin, Wooyoung
    • Communications for Statistical Applications and Methods
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    • v.22 no.6
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    • pp.605-613
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    • 2015
  • A three-arm parallel design has been proposed to assess the biosimilarity between a biological product and a reference product using relative distance (Kang and Chow, 2013). The three-arm parallel design consists of two arms for the reference product and one arm for the biosimilar product. This paper extended the three-arm parallel design to a (k + 1)-arm parallel design composed of k (${\geq}3$) arms for the reference product and one arm for the biosimilar product. A new relative distance was defined based on Euclidean distance; consequently, a corresponding test procedure was developed based on asymptotic distribution. Type I error rates and powers were investigated both theoretically and empirically.

Statistical tests for biosimilarity based on relative distance between follow-on biologics for ordinal endpoints

  • Yoo, Myung Soo;Kim, Donguk
    • Communications for Statistical Applications and Methods
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    • v.27 no.1
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    • pp.1-14
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    • 2020
  • Investigations of biosimilarity between reference drugs and test drugs required statistical tests; in addition, statistical tests to evaluate biosimilarity have been recently proposed. Ordinal outcome data has been observed in research; however, appropriate statistical tests to deal with ordinal endpoints for biosimilar have not yet been proposed. This paper extends existing design for ordinal endpoints. Using measure of nominal-ordinal association and relative distances between drugs are defined so that testing procedures are developed. Through simulation studies, we investigate type I error rate and power to show the performance of our suggested method. Furthermore, a comparison between the statistical tests and other designs is proviede to show significance of ordinal endpoints.

Current issues of pediatric inflammatory bowel disease in Korea

  • Oh, Seak Hee;Kim, Kyung Mo
    • Clinical and Experimental Pediatrics
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    • v.57 no.11
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    • pp.465-471
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    • 2014
  • Inflammatory bowel disease (IBD) is a chronic relapsing disorder of unknown etiology, which is believed to be multifactorial. Recently, the incidence of pediatric IBD has steeply increased in Korea since 2000. Poorly controlled disease activity can result in complications such as intestinal fistulae, abscess, and stricture, as well as growth retardation and delayed puberty in children. Because of a lack of confirmative tests, various diagnostic modalities must be used to diagnose IBD. Onset age, location, behavior, and activity are important in selecting treatments. Monogenic IBD must be excluded among infantile and refractory very-early-onset IBD. Early aggressive therapy using biologics has recently been proposed for peripubertal children to prevent growth failure and malnutrition.