• 약학회지
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• 제55권4호
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• pp.284-288
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• 2011

The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.

• 한국동물위생학회지
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• 제42권4호
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• pp.285-288
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• 2019

Foot-and-mouth disease (FMD) causes economic problems in livestock industry because of fast spread and inducing low productivity. FMD outbreaks occurred in South Korea over the period from 2000 to 2019. Vaccination is the most practical and effective means of controlling or preventing these outbreaks, and a national vaccination policy has been in place for all FMD-susceptible animals since 2010. To prevent and control of FMD, South Korea has been using vaccines imported from the United Kingdom, Argentina, and Russia. The Animal and Plant Quarantine Agency of South Korea oversees continuous quality control of imported FMD vaccines. FMD vaccines were evaluated characteristics, sterility, pH, inactivation, safety, potency test by Korean FMD vaccine standard assay (Test for National Lot Release). The 6 company vaccines (A~F) were used Test for National Lot Release by each method. We evaluated quality of each FMD vaccine from 2015 to 2019. All batch of vaccine showed good quality control and were passed the Test for National Lot Release. The serotypes of vaccine are increasingly changing to multiple vaccine because the FMD was outbreak by various serotype virus in South Korea. Furthermore, this data may be useful as a basis for ensuring the quality of FMD vaccines and for base data to manage them. Additional study is required to simple approach for rapid evaluation of quality and antigen content identification in vaccines.

• KSBB Journal
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• 제25권6호
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• pp.572-576
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• 2010

수두 생바이러스 백신과 같은 생물의약품은 다양한 물질이 복합적으로 구성되어 있어 단순한 물리 화학적 분석방법만으로는 그 특성을 규명할 수 없다. 따라서 이러한 생물의 약품의 품질을 평가하기 위해서는 표준품이 필수적이다. 2002년과 2003년에 제조 및 확립한 1차 국가표준품의 재고량 소진 및 역가 감소에 따라 식품의약품안전평가원에서는 수두 생바이러스 백신의 2차 국가표준품을 확립하기 위하여 2008년 용역연구사업을 통해 국내의 수두 생바이러스 백신 제조회사에서 표준품 후보물질을 제조하였으며, 국가표준품 후보물질의 역가산정을 위하여 국내 제조사 및 식품의약품 안전평가원에서 공동연구를 수행하였다. 국내제조사를 포함한 3개의 공동연구 시험소에서 7회 이상의 반복시험을 수행하여 얻은 공동연구 결과를 통계학적으로 분석한 결과 3곳의 공동연구 시험소의 통합역가에 대한 변이계수 (coefficient variation, CV)는 1.24%로 각 시험소간의 기하평균 (GMT) 변동 수준이 매우 낮음을 확인할 수 있었다. 또한, 수두 생바이러스 백신의 2차 국가표준품의 표시역가는 $4.26\;log_{10}\;PFU$/0.5 mL로 산정하였다.

• 한국안전학회지
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• 제32권5호
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• pp.20-24
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• 2017

In this study, we have performed the Cone Calorimeter test in accordance with ISO 5660-1 to check the combustion characteristics of building flooring materials. The fire risk of these materials were evaluated by construction code, KFI criteria and standards of flame retardant performance. When samples exposed to external heat flux, all samples consumed a lot of Oxygen for a long time. So heat release from sample burning continued so long. And also all samples produced so much smoke. Even though a few samples were satisfied with only peak heat release rate criteria, all 8 samples were not satisfied with criteria of peak heat release rate and total heat released together. The results of 5 min total heat released were $15.9MJ/m^2{\sim}5.9MJ/m^2$. It menas the results are more than 2~6 times higher than the criteria. The results of 10 min total heat released were $30.1MJ/m^2{\sim}100.8MJ/m^2$. It means the results are more than 3~12 times higher than the criteria. 6 of 8 samples were not satisfied with Dm.corr.(corrected maximum smoke density) criteria. The building flooring materials which we used for this test ignited very fast and the burning continued so long. It means these samples are susceptible to fire.

• KSBB Journal
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• 제26권2호
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• pp.157-164
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• 2011

Five assays for anti-HBs were compared to improve potency test of Human lgG preparations. The three commercial EIA kits were optimized including dose response curve ranges and compared by conducting a co-laboratory study. After selecting the most reproducible EIA kit, methods comparison was performed with 22 samples in 5 different days. As a result, EIA (7.7 ${\pm}$ 5.3%) and MEIA (AxSYM: 3.7 ${\pm}$ 1.9%, IMx: 1.6 ${\pm}$ 0.8%) showed precision and accuracy (100.1 ${\pm}$ 12.6%). Therefore, the validated EIA assay was established and it is believed to be comparable to current MEIA.

• Advances in concrete construction
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• 제9권4호
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• pp.345-354
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• 2020

Cement is the most significant component in concrete. Large scale manufacturing of cement consumes more energy and release harmful products (Carbon dioxide) into the atmosphere that adversely affect the environment and depletes the natural resources. A lot of research is going on in globally concentrating on the recycling and reuse of waste materials from many industries. A major share of research is focused on finding cementitious materials alternatives to ordinary Portland cement. Many industrial waste by-products such as quartz powder, metakaolin, ground granulated blast furnace slag, silica fume, and fly ash etc. are under investigations for replacement of cement in concrete to minimize greenhouse gases and improve the sustainable construction. In current research, the effects of a new generation, ultra-fine material i.e., alccofine which is obtained from ground granulated blast furnace slag are studied as partial replacement by 25% and with varying amounts of sulfonated naphthalene formaldehyde (i.e., 0.3%, 0.35% and 0.40%) on mechanical, water absorption, thermal and microstructural properties of concrete. The results showed moderate improvement in all concrete properties. Addition of SNF with combination of alccofine showed a significant enhancement in fresh, hardened properties and water absorption test as well as thermal and microstructural properties of concrete.

• Toxicological Research
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• 제33권3호
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• pp.225-231
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• 2017

National reference standards (NRSs) for biologics are established through potency estimation by a multi-center joint study of standard materials used in the approval process for national lot release and quality control of vaccines, blood products, and other biologics. In this study, a stability evaluation was conducted to determine whether the potency of NRSs for six blood products was being maintained at a consistent level in Korea. The present study conducted real-time stability tests via in-vivo/in-vitro bioassay on NRSs for blood coagulation factor VIII concentrate (2nd standard), antithrombin concentrate, prekallikrein activator, anti-hepatitis B immunoglobulin, blood coagulation factor IX concentrate, and anti-tetanus human immunoglobulin, as well as a trend analysis using cumulative annual results. The real-time stability test results showed that the mean potency of six NRSs was all within the control limit. In the trend analysis, the potency of NRS for blood coagulation factor VIII concentrate (2nd standard) showed a decreasing trend, while the potency of all other products had been stably maintained. The present study confirmed that the mean potency of NRSs for six blood products had been stably maintained in Korea. The findings of the present study establish a foundation that can ensure the quality of NRSs for biologics in Korea, and it is expected to make a major contribution to the supply of high-quality biologics.

• Toxicological Research
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• 제34권3호
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• pp.191-197
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• 2018

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.

• 대한치과교정학회지
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• 제25권1호
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• pp.43-54
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• 1995

TiN 피막 처리된 스테인레스강 교정용 장치물이, 전해질이 있는 구강내에 장기간 장착될 때 발생할 수 있는 금속 유리 정도를 파악하기 위해 상악 편측에 해당하는 모조 교정 장치를 제작하였다. welding을 실시하고 TiN 피막 처리한 시편을 제1군으로, welding을 실시하지 않고 TiN피 막 처리한 시편을 제2군으로, welding을 실시하고 TiN 피막 처리를 하지 않은 시편을 제3군으로 welding과 TiN 피막 처리를 실시하지 않은 시편을 제4군으로 하여 각 군당 10개씩의 시편을 준비하였다. 각 시편을 인공 타액내에 15일간 침적하여 용액 속에 유리되어 용해된 니켈과 크롬의 누계와 침전물 형태로 존재하는 니켈과 크롬의 양을 측정하여 총량의 차이를 TiN 피막 처리 유무와 welding 유무에 따라 t-test로 검정한 결과, welding을 실시한 두 군중 TiN 피막 처리 한 군에서 금속 유리량이 더 적었으며 , TiN 피막 처리한 두 군중 welding을 실시하지 않은 군에서 금속 유리량이 더 적은 것으로 나타났다. 표면 조직 관찰시 welding을 실시한 두 군에서 수많은 침전물과 Pitting corrosion이 보였으며 이 중 TiN 피막 처리한 군에서 그 정도가 낮았다. 본 실험을 통하여 스테인레스강 교정용 장치물에 TiN 피막 처리시 심미성 및 각종 물성의 개선 이외에도 금속 유리의 정량적인 분석 결과 내식성이 현저히 개선됨을 알 수 있었다.

• 대한수의학회지
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• 제62권4호
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• pp.29.1-29.7
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• 2022

Vaccination against Newcastle disease (ND) is the most effective means of controlling the disease, and these vaccines are commercialized only after their safety and effectiveness have been verified through tests that comply with Korean Standards of National Lot Release for Veterinary Biologics. This study investigated whether a relatively convenient and safe serological test can be used in place of the challenge test using highly virulent ND virus. Hemagglutination inhibition (HI) assay and enzyme-linked immunosorbent assay (ELISA) were considered positive of log₂ 2 or more and cutoff value of 200 or more, respectively, in both live and inactivated vaccines. However, when the antibody levels of the live and inactivated vaccines induced using the Ulster 2C, KBNP-C4152R2L, and K148/08 strains were compared, the antibody titers for inactivated vaccines were significantly higher than those for live vaccines in both the HI assay and ELISA. A strong positive correlation was observed between HI and ELISA antibody titers. The live vaccines corresponded to a survival rates of ≥ 80% and the inactivated vaccines corresponded to 100% survival rates. This study confirmed that standard efficacy tests can serve as serological tests, and can replace the challenge test and that the vaccine approval process can be improved.