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The 2nd Meeting of National Control Laboratories for Vaccines and Biologicals in the Western Pacific
Hokyung Oh,장자영 질병관리본부 2018 Osong Public Health and Research Persptectives Vol.9 No.3
The Second Meeting of the National Control Laboratories for Vaccines and Biologicals in the Western Pacific, was jointly organized by the National Institute of Food and Drug Safety Evaluation of the Ministry of Food and Drug Safety in the Republic of Korea, and by the World Health Organization Regional Office for the Western Pacific. In the National Lot Release Systems session countries including Canada, China, Japan, Malaysia, Vietnam, and the Republic of Korea, all shared information on their current Lot Release Systems, including current practices and developments in risk-based official lot release of vaccines. In the session on Quality Control of Blood Products, experts from the National Institute for Biological Standards and Control shared quality control and research results for; blood coagulation factor VIII products, and the measurement of procoagulant activity in immunoglobulin products. Representatives from Japan proposed a regional collaborative study to test aggregated immunoglobulin free from complement activity. A cell-based Japanese encephalitis vaccine potency assay was proposed by representatives from Korea and they also called for voluntary participation of other National Control Laboratories in a collaborative study, on the first Korean Gloydius anti-venom standard. Participants agreed in general to continue communicating, and coordinate presentation of the study results.
A Collaborative Study to Establish the Second Korean National Reference Standard for Snake Venom
Kiwon Han,Kikyung Jung,Hokyung Oh,Hojin Song,Sangmi Park,Ji-Hye Kim,Garam Min,Byung-Hwa Lee,Hyun-sik Nam,Yang Jin Kim,Manabu Ato,Jayoung Jeong,Chiyoung Ahn 한국독성학회 2018 Toxicological Research Vol.34 No.3
In 2015, a candidate for the second national reference standard (NRS) of Gloydius snake venom was produced to replace the first NRS of Gloydius snake venom. In the present study, the potencies of the candidate were determined by a collaborative study, and the qualification of the candidate was estimated. The potencies of the candidate were determined by measuring the murine lethal titers and lapine hemorrhagic titers of venom against the regional working reference standard (RWRS) for antivenom using the methods described in the previous report for the first NRS of Gloydius snake venom. Three Korean facilities contributed data from a total of 30 independent assays. Subsequently, two foreign national control research laboratories contributed to this collaborative study. The results were calculated using the Reed-Muench method for lethality and determined using a mixed-effects model for hemorrhage. The general common potencies of the lethal and hemorrhagic titers were obtained from the results of the 30 tests performed at three Korean facilities. The results are expressed in micrograms for 1 test dose (TD) with a 95% confidence interval as follows: a lethal titer of 90.13 ㎍/TD (95% confidence interval = 87.39~92.86 ㎍) and a hemorrhagic titer of 10.80 ㎍/TD (95% confidence interval = 10.46~11.14 ㎍). In addition, the candidate preparation showed good quality evaluation according to the results of the quality estimation of the candidate and is judged to be suitable to serve as the Korean NRS for snake venom. In conclusion, the second NRS of Gloydius snake venom was established in this study and will be used for national quality control, including a national lot release test of Korean antivenom products.
A Collaborative Study to Establish the Second Korean National Reference Standard for Snake Venom
Han, Kiwon,Jung, Kikyung,Oh, Hokyung,Song, Hojin,Park, Sangmi,Kim, Ji-Hye,Min, Garam,Lee, Byung-Hwa,Nam, Hyun-sik,Kim, Yang Jin,Ato, Manabu,Jeong, Jayoung,Ahn, Chiyoung Korean Society of ToxicologyKorea Environmental Mu 2018 Toxicological Research Vol.34 No.3
In 2015, a candidate for the second national reference standard (NRS) of Gloydius snake venom was produced to replace the first NRS of Gloydius snake venom. In the present study, the potencies of the candidate were determined by a collaborative study, and the qualification of the candidate was estimated. The potencies of the candidate were determined by measuring the murine lethal titers and lapine hemorrhagic titers of venom against the regional working reference standard (RWRS) for antivenom using the methods described in the previous report for the first NRS of Gloydius snake venom. Three Korean facilities contributed data from a total of 30 independent assays. Subsequently, two foreign national control research laboratories contributed to this collaborative study. The results were calculated using the Reed-Muench method for lethality and determined using a mixed-effects model for hemorrhage. The general common potencies of the lethal and hemorrhagic titers were obtained from the results of the 30 tests performed at three Korean facilities. The results are expressed in micrograms for 1 test dose (TD) with a 95% confidence interval as follows: a lethal titer of $90.13{\mu}g/TD$ (95% confidence interval = $87.39{\sim}92.86{\mu}g$) and a hemorrhagic titer of $10.80{\mu}g/TD$ (95% confidence interval = $10.46{\sim}11.14{\mu}g$). In addition, the candidate preparation showed good quality evaluation according to the results of the quality estimation of the candidate and is judged to be suitable to serve as the Korean NRS for snake venom. In conclusion, the second NRS of Gloydius snake venom was established in this study and will be used for national quality control, including a national lot release test of Korean antivenom products.
Multimodal Sensing with a Three-Dimensional Piezoresistive Structure
Won, Sang Min,Wang, Heling,Kim, Bong Hoon,Lee, KunHyuck,Jang, Hokyung,Kwon, Kyeongha,Han, Mengdi,Crawford, Kaitlyn E.,Li, Haibo,Lee, Yechan,Yuan, Xuebo,Kim, Sung Bong,Oh, Yong Suk,Jang, Woo Jin,Lee, J American Chemical Society 2019 ACS NANO Vol.13 No.10
<P>Sensors that reproduce the complex characteristics of cutaneous receptors in the skin have important potential in the context of artificial systems for controlled interactions with the physical environment. Multimodal responses with high sensitivity and wide dynamic range are essential for many such applications. This report introduces a simple, three-dimensional type of microelectromechanical sensor that incorporates monocrystalline silicon nanomembranes as piezoresistive elements in a configuration that enables separate, simultaneous measurements of multiple mechanical stimuli, such as normal force, shear force, and bending, along with temperature. The technology provides high sensitivity measurements with millisecond response times, as supported by quantitative simulations. The fabrication and assembly processes allow scalable production of interconnected arrays of such devices with capabilities in spatiotemporal mapping. Integration with wireless data recording and transmission electronics allows operation with standard consumer devices.</P> [FIG OMISSION]</BR>
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.
Yoon Song Youl,Kang Da Hee,Heo Hye-Ryeon,Ryu Seung-Rel,Lee Chulhyun,Park Eunhye,Kim Jihwa,Oh Hokyung 한국에프디시규제과학회 2024 FDC법제연구 Vol.19 No.1
Human albumin solutions which are used in medical and surgical conditions are required national lot release regulatory before releasing into the market. Testing for the albumin content is the key component and the Kjeldahl method, which can be time-consuming processes and safety concerns regarding sulfuric acid use, is currently the official test method for albumin content in Ministry of Food and Drug Safety, Republic of Korea. In this study, we applied SoloVPE, a new UV-vis spectroscopic technology using a variable path length extension to quantify albumin content for quality control purposes regarding human albumin solution. With its validation, a strong correlation was shown between the Kjeldahl method and SoloVPE. Our findings can help improve the current testing methods for albumin content and provide better quality controls for human albumin solutions.
( Jaesuk Yun ),( Sun Mi Gu ),( Tac-hyung Lee ),( Yun Jeong Song ),( Seonhwa Seong ),( Young-hoon Kim ),( Hye Jin Cha ),( Kyoung Moon Han ),( Jisoon Shin ),( Hokyung Oh ),( Kikyung Jung ),( Chiyoung Ah 한국응용약물학회 2017 Biomolecules & Therapeutics(구 응용약물학회지) Vol.25 No.3
Synthetic cannabinoids are one of most abused new psychoactive substances. The recreational use of abused drug has aroused serious concerns about the consequences of these drugs on infection. However, the effects of synthetic cannabinoid on resistance to tetanus toxin are not fully understood yet. In the present study, we aimed to determine if the administration of synthetic cannabinoids increase the susceptibility to tetanus toxin-induced motor behavioral deficit and functional changes in cerebellar neurons in mice. Furthermore, we measured T lymphocytes marker levels, such as CD8 and CD4 which against tetanus toxin. JWH-210 administration decreased expression levels of T cell activators including cluster of differentiation (CD) 3ε, CD3γ, CD74p31, and CD74p41. In addition, we demonstrated that JWH-210 induced motor impairment and decrement of vesicle-associated membrane proteins 2 levels in the cerebellum of mice treated with tetanus toxin. Furthermore, cerebellar glutamatergic neuronal homeostasis was hampered by JWH-210 administration, as evidenced by increased glutamate concentration levels in the cerebellum. These results suggest that JWH-210 may increase the vulnerability to tetanus toxin via the regulation of immune function.
Yun, Jaesuk,Gu, Sun Mi,Lee, Tac-hyung,Song, Yun Jeong,Seong, Seonhwa,Kim, Young-Hoon,Cha, Hye Jin,Han, Kyoung Moon,Shin, Jisoon,Oh, Hokyung,Jung, Kikyung,Ahn, Chiyoung,Park, Hye-Kyung,Kim, Hyung Soo The Korean Society of Applied Pharmacology 2017 Biomolecules & Therapeutics(구 응용약물학회지) Vol.25 No.3
Synthetic cannabinoids are one of most abused new psychoactive substances. The recreational use of abused drug has aroused serious concerns about the consequences of these drugs on infection. However, the effects of synthetic cannabinoid on resistance to tetanus toxin are not fully understood yet. In the present study, we aimed to determine if the administration of synthetic cannabinoids increase the susceptibility to tetanus toxin-induced motor behavioral deficit and functional changes in cerebellar neurons in mice. Furthermore, we measured T lymphocytes marker levels, such as CD8 and CD4 which against tetanus toxin. JWH-210 administration decreased expression levels of T cell activators including cluster of differentiation (CD) $3{\varepsilon}$, $CD3{\gamma}$, CD74p31, and CD74p41. In addition, we demonstrated that JWH-210 induced motor impairment and decrement of vesicle-associated membrane proteins 2 levels in the cerebellum of mice treated with tetanus toxin. Furthermore, cerebellar glutamatergic neuronal homeostasis was hampered by JWH-210 administration, as evidenced by increased glutamate concentration levels in the cerebellum. These results suggest that JWH-210 may increase the vulnerability to tetanus toxin via the regulation of immune function.