• YAKHAK HOEJI
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• v.55 no.4
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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.

• Korean Journal of Veterinary Service
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• v.42 no.4
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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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• v.25 no.6
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• pp.572-576
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• 2010

Biological products, such as live varicella vaccine, are composed of biological substances derived from biological organisms. It is very difficult to identify these biologics' characteristics by analysis of simple physical and chemical methods alone. So the reference material is essential in order to evaluate the quality of bilogics. The 1'st national standard for varicella live vaccine was manufactured, established in 2002 and 2003, and have been used for the manufacturer's quality control and national lot release since then. As the lack of its availability and the decrease of its stability, this study was initiated by National Institute of Food and Drug Safety Evaluation (NiFDS) in 2008 to manufacture and establish the 2nd national standard for varicella live vaccine. The candidate material was manufactured from one of domestic manufacterers and the joint research of the NiFDS and manufacturers of varicella live vaccine was conducted to estimate of the reliable virus content. In the collaborative study, 3 laboratories including NiFDS performed the virus content test more than 7 times and all assay results were statistically analyzed. The mean coefficient of variation (CV) was 1.24%, and the geometric mean titre (GMT) variation range of each laboratory was low. On the basis of the results of this study, the candidate material of 2nd national standard for varicella live vaccine was assigned a potency of 4.26 log10 pfu/0.5 mL, when reconstituted in 0.7 mL.

• Journal of the Korean Society of Safety
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• v.32 no.5
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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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• v.26 no.2
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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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• v.9 no.4
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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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• v.33 no.3
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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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• v.34 no.3
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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.

• The korean journal of orthodontics
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• v.25 no.1 s.48
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• pp.43-54
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• 1995

This study was conducted to examine the metal release of TiN-plated stainless steel orthodontic appliances by constructing the simulated orthodontic appliances equivalent to maxillary half arch, by dividing into TiN-plated and TiN-nonplated Bloops and by dividing again these groups into welded and nonwelded groups. And then, the total quantity of metal release was obtained by measuring the amounts of both soluble and precipitated nickel and chromium after immersing in artificial saliva for 15 days. And then, the corrosion appearance of surface structure was observed by using SEM. The results of this study were summarized as follows. 1. The total amounts of released nickel and chromium showed that the TiN-plated group after welding(Group 1) was 25.46 ${\mu}g$, respectively, and 17.4 ${\mu}g$, while the TiN-nonplated group after welding(Group III) was 54.69 ${\mu}g$, respectively, and 85.27 ${\mu}g$. Then, the TiN-Plated group indicated less amounts of metal release(p<0.05). 2. The total amounts of the TiN-plated group without welding(Group II) was 0.05${\mu}g$ and 0.34${\mu}g$, respectively. Then, it was shown that the TiN-plated group without welding(Group II) indicated less metal release than that of the TiN-Plated group after welding(Group I)(p<0.01, p<0.05). 3. When observing their surface structure, there were a lot of precipitate and pitting corrosion in the groups with welding(Group I & III), when the TiN-plated group(Group I) showed lower level than the TiN-nonplated group(Group IIII). On the other hand, the groups without welding(Group II & IV) indicated a little of pitting corrosion. 4. In case of observation with the naked eyes, it was shown that there were significant disco1oration and corrosion in the groups with welding(Group I & III), while there was no any remarkable change in the groups without welding(Group II & IV).

• Korean Journal of Veterinary Research
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• v.62 no.4
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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.