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외래성 Minute Virus of Mice 검출을 위한 시험법 개발에 관한 연구
정지원(Jeewon Joung),이숙연(Sookyeon Lee),장석기(Seokkee Chang),정자영(Jayoung Jeong),손여원(Yeowon Sohn) 한국실험동물학회 2005 Laboratory Animal Research Vol.21 No.1
In manufacturing of biotechnological products, numerous adventitious agents might have been detected in cell substrates. Recently a biotech-pharmaceutical company has had experienced with contamination of large-scale cell cultures by minute virus of mice (MVM) and this resulted in both the loss of product and the need for major cleaning validation procedures to be put in place. We have developed a simple PCR assay to detect the presense of MVM in cell culture supernatant. The specificity of MVM was determined by testing viral preparations of other autonomous parvovirus and MVM specific PCR assay detects only in the presence MVM viral DNA. This assay has proven to be very sensitive and it can detect 10 or fewer genome equivalents (copies) of MVM. These results implicate that we may use this assay for routine screening test for MVM. The assay also can detect MVM following extraction procedure of DNA in cell lines at a concentration of 1 TCID₅₀/㎖ and establishes a sensitive, specific assay that can detect the presense of MVM sequences in a cell culture system.
국내 허가 및 긴급사용승인된 코로나19 바이러스감염증 치료제의 허가사항 비교 고찰
최민정(Min Joung Choi),서현옥(Hyun Ok Seo),도희정(Hea Jeong Doh),김영림(Younglim Kim),최경숙(Kyoung Suk Choi),박윤주(Younjoo Park),서경원(Kyung Won Seo),정지원(Jeewon Joung),김지연(Ji Yeon Kim),박인숙(In Suk Park),이원재(Wonjae Lee) 대한약학회 2023 약학회지 Vol.67 No.3
In a situation where the development of various treatments is urgently needed to overcome the global outbreak of coronavirus disease 2019 (COVID-19) and the sequential emergence of new variant viruses, Ministry of Food and Drug Safety (MFDS) made tremendous efforts to promptly supply the safe and effective therapeutics manufactured by local and global companies through accelerated marketing authorization or emergency use approvals. To date, seven products (including overlapped) have received marketing authorization or emergency use approvals from MFDS, and their indicated patient group according to the severity, efficacy, and safety information are different by each products. Therefore, this study is to compare the product information and the major clinical outcomes obtained from clinical studies of COVID-19 treatments authorized or approved for emergency use in Korea and to introduce the MFDS’s efforts for establishment of accelerated approval system for COVID-19 treatment and development of relevant guidelines. It is hoped that this study will serve as a reference for the latecomers who is preparing the development of therapeutics for emerging infectious diseases in the future.
김소영(So Young Kim),이선미(Sunmi Lee),전솔(Sol Jeon),양미숙(Misook Yang),이철현(Chulhyun Lee),정지원(Jeewon Joung),이윤건(Youngun Lee),박선영(Sunyoung Park),홍진태(Jin Tae Hong),김종원(Jong Won Kim) 대한약학회 2021 약학회지 Vol.65 No.3
This study aimed to establish a national reference standard for the purified Vi typhoid vaccine. The first national standard for the typhoid vaccine established in 2009 is currently outdated; hence, Boryung Biopharma Co. produced 4,070 vials of a candidate vaccine as per the second standard outlined in 2018. The large-scale manufacture of the standard candidate was guaranteed through quality tests and accelerated and long-term stability tests. Reference standards ensure the accuracy and reliability of the results of quality control tests for vaccines. Thus, a collaborative study was conducted to estimate the potency of the candidate material as per the second national standard using the test methods of HPAEC-PAD (High Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection) and rocket immunoelectrophoresis. The HPAEC-PAD result was 51.5 μg/vial (95% confidence interval [CI]: 50.70-52.29 μg/vial). On the other hand, the rocket assay result was 63.4 μg/vial (95% CI: 61.08-65.89 μg/vial). In addition, the precision and proficiency of the institutes was confirmed by the CV and robust Z-score, respectively. The candidate will be registered for use as the second national standard for the purified Vi typhoid vaccine after evaluating its long-term stability. After registration, it will contribute to securing the reliability and consistency of the quality control test results for typhoid vaccines by being used in the national release system and quality control of the manufacturer.