One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body's defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher's knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.
Journal of the Korean Society of International Agriculture
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v.43
no.2
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pp.54-63
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2019
Forensic science is an academic field that utilizes scientific knowledge and the conducting of research in legal procedures. Recently, legal science has been receiving more attention since the use of DNA identification started, especially in criminal procedures, in accordance with the development of human genetics. DNA identification has been used to identify criminals by analyzing humanoriginated biological materials obtained from crime scenes, and, more recently, the breadth and effectiveness of their use has been increasing with the operation of DNA databases. The Korean government regulates the operation and utilization of the DNA database through the "Act on Use and Protection of DNA Identification Information." Meanwhile, the actual study of human genetics is regulated by the "Bioethics and Safety Act." Professional areas, such as forensic science, are not areas where regulation by the laws is appropriate. However, the core part of behavior has to be ruled by the laws, considering the impact of scientific achievements on society and individuals when they are utilized. Since most scientific research and performance utilization belong in the scientific and technological domains, regulation through experts' autonomous guidelines is more appropriate. For the regulation of biomedical research through ethical guidelines, some requirements should be satisfied: the ethical guideline should be made by suitable professionals; the ethical guideline should be scientifically and ethically reliable; the ethical guideline should be enforced by a trustworthy institution; and most importantly, the scientist community should be trustworthy.
Chili pepper anthracnose, caused by Colletotrichum spp., is a significant biotic stress affecting chili fruits globally. While fungicide application is commonly used for disease management due to its efficiency and cost-effectiveness, excessive use poses risks to human health and the environment. Botanical fungicides offer advantages such as rapid degradation and low toxicity to mammals, making them increasingly popular for sustainable plant disease control. This study investigated the antifungal properties of Cestrum tomentosum L.f. crude extracts (CTCE) against Colletotrichum scovillei. The results demonstrated that CTCE effectively inhibited conidia germination and germ tube elongation at 40 ㎍/ml concentrations. Moreover, CTCE exhibited strong antifungal activity against C. scovillei mycelial growth, with an EC50 value of 18.81 ㎍/ml. In vivo experiments confirmed the protective and curative effects of CTCE on chili pepper fruits infected with C. scovillei. XTT analysis showed that the CTCE could significantly inhibit the cell viability of C. scovillei. Mechanistic studies revealed that CTCE disrupted the plasma membrane integrity of C. scovillei and induced the accumulation of reactive oxygen species in hyphal cells. These findings highlight CTCE as a promising eco-friendly botanical fungicide for managing C. scovillei infections in chili peppers.
Ham, S.K.;Song, T.H.;Zhang, G.Q.;Hur, S.N.;Park, H.S.
Korean Journal of Poultry Science
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v.33
no.3
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pp.233-238
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2006
In order to study the effect of feeding rare earth(RE) on growth of broiler chicks, feed conversion ratio, and probable harmfulness of feeding high levels of RE, two feeding trials with broiler chicks were conducted; one using a commercial broiler compound feed and the other using a self mixed feed excluding any growth stimulating feed additives. The the first trial used three hundred sixty of one day old Cobb broiler chicks for six levels of dietary supplementation of RE : 0, 100, 200, 400, 800 and 1,600 mg/kg. There were significant effect of RE stimulating broiler chick growth and improving feed conversion ratio, The dietary supplementation of RE at a level of 100 mg/kg was the best of all and increased body weight gain by 8.9% (p<0.05). Chicks fed RE at a level of 1,600 mg/kg grew as good as chicks fed feeds without RE and did not show my abnormalities. The second feeding trial was conducted in the same manner as the first trial using Ross broiler chicks and self-mixed experimental diets supplemented with RE at levels of 0, 50, 100 and 150 mg/kg. Differently from Results of the first trial, body weight gain and feed conversion ratio of were the best at the level of 50 mg/kg RE supplementation(p<0.05). In this trial all the birds fed RE showed significantly lower ratio of abdominal fat against live weight than those of the control group birds. Overall, it can be said that dietary supplementation of RE will improve broiler growth and feed conversion ratio and the proper dietary level would be $50\sim100mg/kg$. These results suggested that the proper level of RE for broiler chicks would be 50 to 100 mg/kg and its effectiveness is varied depending upon RE mixture. There appears abdominal fat of broiler chicks is decreased by feeding RE but further investigation is in need.
Viral safety is an important prerequisite for clinical preparations of all biopharmaceuticals derived from plasma, cell lines, or tissues of human or animal origin. To ensure the safety, implementation of multiple viral clearance (inactivation and/or removal) steps has been highly recommended for manufacturing of biopharmaceuticals. Of the possible viral clearance strategies, Ultraviolet-C (UVC) irradiation has been known as an effective viral inactivating method. However it has been dismissed by biopharmaceutical industry as a result of the potential for protein damage and the difficulty in delivering uniform doses. Recently a continuous flow UVC reactor (UVivatec) was developed to provide highly efficient mixing and maximize virus exposure to the UV light. In order to investigate the effectiveness of UVivatec to inactivate viruses without causing significant protein damage, the feasibility of the UVC irradiation process was studied with a commercial therapeutic protein. Recovery yield in the optimized condition of $3,000\;J/m^2$ irradiation was more than 98%. The efficacy and robustness of the UVC reactor was evaluated with regard to the inactivation of human immunodeficiency virus (HIV), hepatitis A virus (HAV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), porcine parvovirus (PPV), bovine parvovirus (BPV), minute virus of mice (MVM), reovirus type 3 (REO), and bovine parainfluenza virus type 3 (BPIV). Non enveloped viruses (HAV, PPV, BPV, MVM, and REO) were completely inactivated to undetectable levels by $3,000\;J/m^2$ irradiation. Enveloped viruses such as HIV, BVDV, and BPIV were completely inactivated to undetectable levels. However BHV was incompletely inactivated with slight residual infectivity remaining even after $3,000\;J/m^2$ irradiation. The log reduction factors achieved by UVC irradiation were ${\geq}3.89$ for HIV, ${\geq}5.27$ for HAV, 5.29 for BHV, ${\geq}5.96$ for BVDV, ${\geq}4.37$ for PPV, ${\geq}3.55$ for BPV, ${\geq}3.51$ for MVM, ${\geq}4.20$ for REO, and ${\geq}4.15$ for BPIV. These results indicate that UVC irradiation using UVivatec was very effective and robust in inactivating all the viruses tested.
Kim, Ik Hyun;Dan, Seungkyu;Cho, Seonghyun;Lee, Gibaek;Yoon, En Sup
Korean Chemical Engineering Research
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v.52
no.4
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pp.467-474
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2014
Preliminary design in chemical process furnishes economic feasibility through calculation of both mass balance and energy balance and makes it possible to produce a desired product under the given conditions. Through this design stage, the process possesses unchangeable characteristics, since the materials, reactions, unit configuration, and operating conditions were determined. Unique characteristics could be very economic, but it also implies various potential risk factors as well. Therefore, it becomes extremely important to design process considering both economics and safety by integrating process simulation and quantitative risk analysis during preliminary design stage. The target of this study is LNG liquefaction process. By the simulation using Aspen HYSYS and quantitative risk analysis, the design variables of the process were determined in the way to minimize the inherent explosion risks and operating cost. Instead of the optimization tool of Aspen HYSYS, the optimization was performed by using stochastic optimization algorithm (Covariance Matrix Adaptation-Evolution Strategy, CMA-ES) which was implemented through automation between Aspen HYSYS and Matlab. The research obtained that the important variable to enhance inherent safety was the operation pressure of mixed refrigerant. The inherent risk was able to be reduced about 4~18% by increasing the operating cost about 0.5~10%. As the operating cost increases, the absolute value of risk was decreased as expected, but cost-effectiveness of risk reduction had decreased. Integration of process simulation and quantitative risk analysis made it possible to design inherently safe process, and it is expected to be useful in designing the less risky process since risk factors in the process can be numerically monitored during preliminary process design stage.
Stone cultural heritages in Korea are mostly situated out door without any notable protection thus there are severe damage from chemical and biological weathering. This in turn, causes deformation and structural damage. To counter act this problem and to increase durability, various kinds of conservation materials are used in the conservation and restoration treatment. However, there are not many practical and technological experiment done on this subject. This paper attempts quantitative evaluation of effectiveness of ethylsilicate based resin for Namsan granite in Gyeongju. When two different materials with different ethylsilicate concentration were compared, the result indicated decrease of absorption and porosity with increase of ultrasonic velocities, uniaxial compressive strength, elastic constant, tensile strength and Poisson's ratio. In addition, comparison of physical characteristic of the conservation material resulted favorably toward ones with higher concentration of ethylsilicate. This is due to the ethylsilicates characteristic to fill the internal pores of stone. There is discolouration of stone surface after treatment with conservation material. This was more prominent with the product of higher ethylsilicate concentration.
The study aims to suggest the direction of improvement in presenting the exhibition space by examining the current status quo of children's science exhibitions in order to enhance the educational effectiveness Children's Science Museum. For this purpose, the children's science museum exhibition and exhibition space were categorized into three themes largely according to the exhibition contents, and an analysis framework was developed to analyze exhibition media and exhibition space. For the research subjects, we selected 7 exhibition halls targeted at children in Korea, collected data via video-taping, and analyzed based on the framework of analysis. When analyzing the display situation in which the exhibits have the contents of 'body', 'peripheral things', and 'natural phenomena', we found that the exhibits are composed of too difficult contents to understand, which do not fit the children's developmental level, and the major media used are observational and explaining media. Additionally, concerning the exhibition space, there is a tendency to rely on the installation elements and color effect. It is also difficult to deduce the contents of the exhibits and the entire story. We suggest that the entire exhibition planning be carefully made from the beginning to improve the current status and enhance the educational effectiveness of the Children's Science Museum with the help of experts.
Byeon, Kyu Deok;Kim, Ga Young;Lee, Inju;Lee, Saeromi;Park, Jaeroh;Hwang, Taemun;Joo, Jin Chul
Journal of Korean Society of Environmental Engineers
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v.38
no.7
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pp.387-394
/
2016
Commercial 28 algae removal technologies that have been applied in domestic rivers and lakes with green tide were investigated, analyzed and classified. The classification of algae removal technologies was based on the three criteria (i.e., principle, flow rate of water body, and application period). Also, algae removal technologies were evaluated in terms of cost effectiveness, field applicability, effect durability, and eco friendliness. From the analysis results, technologies using physical, chemical, biological, and convergent controls were 32.2%, 25%, 21.4%, and 21.4%, respectively. The 75% of technologies have been applied to stagnant water body (${\leq}0.2m/s$). Also, algae harvesting ship with dissolved air flotation, conveyor belt and filtration processes and natural floating coagulant were found to have better field applicability, compared to other technologies. However, proper algae removal technology in specific rivers and lakes should be chosen after the evaluation of long-term pilot scale field test. Also, development of energy and resource recovery technologies from algae biomass is warranted.
Journal of Korean Society of Environmental Engineers
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v.32
no.3
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pp.234-240
/
2010
The effectiveness of adding powdered zeolite and granular activated carbon (GAC) before starvation into biological reactor for recovering its performances was investigated. Two types of carrier addition in Sequencing Batch Reactor (SBR) system for non-saline and saline wastewater were evaluated after starvation periods. During the experiment, settleablity (SVI), floc size, fractal dimension, $COD_{Mn}$, T-N, T-P removal efficiencies and recovery time were monitored. When the wastewater feeding was resumed after starvation period for 5days, the SVI increased at the beginning of resumption and then decreased with time in both types. And the larger the floc size and fractal dimension of floc, the more increased removal efficiency for $COD_{Mn}$, T-N and T-P was also. Its performance recovery was strongly correlated with floc size and fractal dimension of activated sludge. After resuming the wastewater feeding, the SVI, floc size, fractal dimension, $COD_{Mn}$, T-N, T-P removal efficiency of SBR with carrier improved and reached its initial value faster compared to those of SBR without carrier.
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