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Joon Ho Eom,Eunhye Park,Ki Dae Park,Sun Hee Kim,So Yeong Kang,Il Ung Oh,Sun Young Baek 한국당과학회 2013 한국당과학회 학술대회 Vol.2013 No.1
Glycan of glycoprotein drugs, which are over 70 % of recombinant DNA products, is a very important evaluation factor in product development or quality evaluation, because it was known as have important roles in both medicinal effects and stability. Especially, in case of biosimilar drugs, which are being recently actively developed, for proving similarity with their innovator, comparative analysis of glycan structure has come to the core as a fundamental evaluation factor. Therefore we desired to establish the useful scientific foundation for quality evaluation and approval evaluation of glycoprotein drugs, thereby establishing standardized glycan analysis methods for glycoprotein drugs using high-tech mass spectrometer in this study. To achieve this, we proposed glycan analysis methods and confirmed these methods, by testing human IgG as glycoprotein and on sale glycoprotein drugs(Infliximab and Trastuzumab). As a result, we established simplified sample preparation method in comparison time-consuming other researches and check method whether or not glycosylation using deglycosylation enzyme treatment and MALDI-TOF-MS. We also established glycosylation pattern and glycan sequence qualtitative analysis method using MALDI-TOF-MS, which has advantage of rapid analysis, and glycan relatively quantitative analysis method using LC-QTOF-MS, which has advantage of quantitative analysis. Established MALDI-TOF-MS method can use to check sample preparation properly and to analyze glycosylation pattern and glycan sequence qualitatively. For relatively quantitative analysis of glycan content and precisely qualitative analysis of glycosylation pattern and glycan sequence, LC-QTOF-MS is more effective than MALDI-TOF-MS. In addition, we proposed glycosylation site analysis method and confirmed the method using LC-QTOF-MS and glycan database. Through this study, we established total five SOPs(Standard Operating Procedures); ① Glycosylation ascertainment test by MALDI-MS, ② Glycan qualtitative analysis by MALDI-MS, ③ Glycan qualitative and quantitative analysis by LC-MS, ④ Glycosylation site analysis by LC-MS, ⑤ Sample preparation ascertainment test by MALDI-MS. These SOPs can be useful in characterizaion of biosimilars.
국내 허가된 유전자재조합의약품 품질시험에 사용되는 전하변이체 분석법 조사연구
엄준호(Joon Ho Eom),백정희(Jounghee Baek),홍영기(Young Ki Hong),손애라(Aera Son),강소영(Soyeong Kang),오호경(Hokyung Oh),김민정(Min-Jung Kim),우정남(Jeong-Nam Woo),안치영(Chiyoung Ahn) 대한약학회 2020 약학회지 Vol.64 No.1
Analysis on approval documents of recombinant DNA-derived biopharmaceuticals (172 items) marketed in Korea showed as followed. First of all, antibody drugs are about 37% among the biopharmaceuticals and most of antibodies as a major ingredient (about 92%) are humanized or human type. Second, charge variant assays using in quality (purity) test are distinctly different between antibody drugs and non-antibody drugs. The former prefer CEX and cIEF, the latter IEF and CZE. The preference difference may be related to size and complexity of target molecules. Third, the result of analysis on usage of 4 assays (CEX, CZE, IEF, and cIEF) in accordance with approval period indicated that cIEF usage got increased since 2010 and was about 50% after 2015. And finally, acceptance criteria of charge variant assays showed a few distinguished patterns independent of drug products. In the light of these facts, whether or not to establish a charge variant method and acceptance criteria as a quality test, and which method to use may depend on the characteristics of the product and analysis conditions of other manufacturers. In particular, in biopharmaceuticals that contain polymer proteins as the main component, such as antibodies, charge variant analysis is important, and the use of modern analytical methods such as the icIEF method is expected to increase.
Nam, Byung Ho,Kim, Young-Woo,Reim, Daniel,Eom, Bang Wool,Yu, Wan Sik,Park, Young Kyu,Ryu, Keun Won,Lee, Young Joon,Yoon, Hong Man,Lee, Jun Ho,Jeong, Oh,Jeong, Sang Ho,Lee, Sang Eok,Lee, Sang Ho,Yoon, The Korean Gastric Cancer Association 2013 Journal of gastric cancer Vol.13 No.3
Purpose: Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. Materials and Methods: Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopyassisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. Discussion: Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).
Eom, Taeyong,Choi, Seol,Choi, Byung Joon,Lee, Min Hwan,Gwon, Taehong,Rha, Sang Ho,Lee, Woongkyu,Kim, Moo-Sung,Xiao, Manchao,Buchanan, Iain,Cho, Deok-Yong,Hwang, Cheol Seong American Chemical Society 2012 Chemistry of materials Vol.24 No.11
<P>Phase change random access memory appears to be the strongest candidate for next-generation high density nonvolatile memory. The fabrication of ultrahigh density phase change memory (≫1 Gb) depends heavily on the thin film growth technique for the phase changing chalcogenide material, most typically containing Ge, Sb and Te (Ge–Sb–Te). Atomic layer deposition (ALD) at low temperatures is the most preferred growth method for depositing such complex materials over surfaces possessing extreme topology. In this study, [(CH<SUB>3</SUB>)<SUB>3</SUB>Si]<SUB>2</SUB>Te and stable alkoxy-Ge (Ge(OCH<SUB>3</SUB>)<SUB>4</SUB>) and alkoxy-Sb (Sb(OC<SUB>2</SUB>H<SUB>5</SUB>)<SUB>3</SUB>) metal–organic precursors were used to deposit various layers with compositions lying on the GeTe<SUB>2</SUB>–Sb<SUB>2</SUB>Te<SUB>3</SUB> tie lines at a substrate temperature as low as 70 °C using a thermal ALD process. The adsorption of Ge precursor was proven to be a physisorption type while other precursors showed a chemisorption behavior. However, the adsorption of Ge precursor was still self-regulated, and the facile ALD of the pseudobinary solid solutions with composition (GeTe<SUB>2</SUB>)<SUB>(1-x)</SUB>(Sb<SUB>2</SUB>Te<SUB>3</SUB>)<SUB><I>x</I></SUB> were achieved. This chemistry-specific ALD process was quite robust against process variations, allowing highly conformal, smooth, and reproducible film growth over a contact hole structure with an extreme geometry. The detailed ALD behavior of binary compounds and incorporation behaviors of the binary compounds in pseudobinary solid solutions were studied in detail. This new composition material showed reliable phase change and accompanying resistance switching behavior, which were slightly better than the standard Ge<SUB>2</SUB>Sb<SUB>2</SUB>Te<SUB>5</SUB> material in the nanoscale. The local chemical environment was similar to that of conventional Ge<SUB>2</SUB>Sb<SUB>2</SUB>Te<SUB>5</SUB> materials.</P><P><B>Graphic Abstract</B> <IMG SRC='http://pubs.acs.org/appl/literatum/publisher/achs/journals/content/cmatex/2012/cmatex.2012.24.issue-11/cm300539a/production/images/medium/cm-2012-00539a_0010.gif'></P><P><A href='http://pubs.acs.org/doi/suppl/10.1021/cm300539a'>ACS Electronic Supporting Info</A></P>
Eom, Bang Wool,Kim, Young-Woo,Nam, Byung-Ho,Ryu, Keun Won,Jeong, Hyun-Yong,Park, Young-Kyu,Lee, Young-Joon,Yang, Han-Kwang,Yu, Wansik,Yook, Jeong-Hwan,Song, Geun Am,Youn, Sei-Jin,Kim, Heung Up,Noh, Su The Korean Gastric Cancer Association 2016 Journal of gastric cancer Vol.16 No.3
Purpose: This study aimed to establish a large-scale database of patients with gastric cancer to facilitate the development of a nationalcancer management system and a comprehensive cancer control policy. Materials and Methods: An observational prospective cohort study on gastric cancer was initiated in 2010. A total of 14 cancer centers throughout the country and 152 researchers were involved in this study. Patient enrollment began in January 2011, and data regarding clinicopathological characteristics, life style-related factors, quality of life, as well as diet diaries were collected. Results: In total, 4,963 patients were enrolled until December 2014, and approximately 5% of all Korean patients with gastric cancer annually were included. The mean age was $58.2{\pm}11.5$ years, and 68.2% were men. The number of patients in each stage was as follows: 3,394 patients (68.4%) were in stage IA/B; 514 patients (10.4%), in stage IIA/B; 469 patients (9.5%), in stage IIIA/B/C; and 127 patients (2.6%), in stage IV. Surgical treatment was performed in 3,958 patients (79.8%), endoscopic resection was performed in 700 patients (14.1%), and 167 patients (3.4%) received palliative chemotherapy. The response rate for the questionnaire on the quality of life was 95%; however, diet diaries were only collected for 27% of patients. Conclusions: To provide comprehensive information on gastric cancer for patients, physicians, and government officials, a large-scale database of Korean patients with gastric cancer was established. Based on the findings of this cohort study, an effective cancer management system and national cancer control policy could be developed.
Lead, Mercury, and Cadmium Exposure in the Korean General Population
Eom, Sang-Yong,Lee, Young-Sub,Lee, Seul-Gi,Seo, Mi-Na,Choi, Byung-Sun,Kim, Yong-Dae,Lim, Ji-Ae,Hwang, Myung-Sil,Kwon, Ho-Jang,Kim, Yu-Mi,Hong, Young-Seoub,Sohn, Seok-Joon,Park, Kyung Su,Pyo, Hee-Soo,K KOREAN ACADEMY OF MEDICAL SCIENCE 2018 JOURNAL OF KOREAN MEDICAL SCIENCE Vol.33 No.2
<P><B>Background</B></P><P>Lead (Pb), mercury (Hg), and cadmium (Cd) are well-known environmental pollutants. They are unnecessary in the biological processes of humans. This study was performed to estimate the representative background exposure levels to the metals by measuring concentrations in whole blood of the Korean general population.</P><P><B>Methods</B></P><P>This population-based cross-sectional study included 4,000 subjects (1,886 males and 2,114 females) 0–83 years of age in 2010 and 2011. Adult subjects (≥ 19 years of age) were collected by sex- and age-stratified probability method, and preschool- and school-aged subjects were recruited by a cluster sampling method. Written consent was provided prior to blood sampling. Pb and Cd blood concentrations were determined by a flameless atomic absorption spectrophotometry, and blood Hg was analyzed by a direct Hg analyzer.</P><P><B>Results</B></P><P>The geometric mean, median and 95th percentile of blood Pb was 1.82 µg/dL, 1.83 µg/dL, and 3.78 µg/dL, respectively. The respective values were 2.92 µg/L, 2.87 µg/L, 9.12 µg/L for Hg, and 0.56 µg/L, 0.59 µg/L, 2.20 µg/L for Cd. Blood Pb and Hg were higher in males than in females, but no sex difference was observed, respectively, in subjects 0–4 years of age for Pb and in subjects less than 20 years for Hg. However, blood Cd was higher in females than in males and no sex difference was observed in subjects < 30 years of age.</P><P><B>Conclusion</B></P><P>This study provides representative data of human exposure to Pb, Hg, and Cd covering whole age groups of the general population in Korea.</P>