• Korean Journal of Fisheries and Aquatic Sciences
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• v.53 no.2
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• pp.237-243
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• 2020

Listeria sp. is one of the pathogenic bacteria causes the infection listeriosis, through mainly raw food such as fishery food, dairy food and vegetables. Listeria sp. is a Gram-positive, non-spore-forming, motile, and facultative anaerobic bacterium. Because of the tolerance of Listeria sp. to low temperature and high salt concentration, it is very difficult to prevent them contaminated in the food, which do not require heating, especially, such as raw fishery products. So prevention and removal of bacterial contamination at the food manufacturing stage is the best method. In this study, therefore, several natural products including Psidium guajava and Geranium thunbergii were screened to investigate the antibacterial activity against Listeria sp., with expectation of fewer side effects and fewer resistance problems. Significant effects of two extracts were confirmed by well diffusion assay, MIC assay, and growth inhibition assay. P. guajava and G. thunbergii showed MIC values at 64-256 ㎍/mL meaning strong antibacterial activities against 6 kind of Listeria sp. tested. And the growth of Listeria sp. in the liquid media was actually inhibited by the addition of these two extracts.

• Journal of Digital Convergence
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• v.20 no.1
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• pp.47-54
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• 2022

The purpose of this study was to derive policy priorities for fostering the biopharmaceutical industry. In this study, the urgency and importance of the policy to foster the biopharmaceutical industry in Gyeonggi-do was investigated, and the priorities of the policy in the biopharmaceutical industry were analyzed through IPA analysis. As a result of the study, the top priority support tasks for the biopharmaceutical industry promotion policy were 'R&D support', 'Expert training', and 'commercialization support'. As a result of deriving policy priorities for each biopharmaceutical sector, 'R&D support' and 'Expert training' were found to be high in common, and differences in policy priorities for each industry such as cell therapy products and advanced bio-convergence products were confirmed. Also, as for the policy demand, R&D funding support, clinical trial support, and commercialization funding support were found to be high. Based on these results, the government's policy to foster the biopharmaceutical industry was supported with a focus on 'R&D support' and 'Expert training', and policy implications were drawn that customized support is needed in consideration of the characteristics of each industry field.

• Korean Journal of Fisheries and Aquatic Sciences
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• v.56 no.5
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• pp.721-727
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• 2023

This study was conducted to evaluate the level of microbial contamination in smoked salmon products sold in hypermarkets in major metropolitan cities in Korea. Listeria monocytogenes is the primary cause of smoked and raw salmon product recalls. Here, we used L. monocytogenes as a bacterial hygiene indicator and investigated the microbial contamination level of frozen/refrigerated smoked salmon products collected from hyper markets. Contamination levels were analyzed by seasons, manufacturers, and consumption regions. For hygiene indicator bacteria, total bacteria count, coliforms, and Escherichia coli were examined according to the food code established by the Ministry of Food and Drug Safety, and polymerase chain reaction (PCR) was performed to detect Listeria sp. The highest contamination level was observed in spring in Busan among five consumption regions. Listeria was detected at a level of 2.1% among all samples collected. And especially L. monocytogenes was detected in two cases from the samples collected from Daegu and Daejeon. Sanitary standards and specifications should be established according to the contamination level of smoked salmon products investigated in this study, and continuous monitoring is necessary.

• Asian Journal of Innovation and Policy
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• v.8 no.2
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• pp.180-207
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• 2019

This article explores the historical evolutionary process of the biopharmaceutical industry of Korea, and how intentional and unintentional policy interventions have triggered the creation of the industry's system dynamics and paved the way for the generation of a few global leading products, including biosimilar, as well as next-generation therapeutics of gene and cell. The policies cover the simple technology transfer of API synthesis to overcome the endemic parasitic disease, new substance patent adoption and new drug development consortia, human resource development, various national initiatives influenced by the Human Genome Project, and venture promotion schemes. The scope and implementation tools under these policies have been aligned and refined to transform traditional fine chemical-based pharmaceuticals, to stimulate large companies' participation and to create technology-based venture companies in the biopharma business of Korea.

• Journal of the Korean Applied Science and Technology
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• v.23 no.4
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• pp.340-346
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• 2006

The influences of fluorescence, scattering, and flocculation in turbid material by light scattering were interpreted for the scattered fluorescence intensity and wavelength, it has been studied the molecular properties by the spectroscopy of laser induced fluorescence (LIF). The effects of optical properties in scattering media have been found by the optical $parameters({\mu}_s,\;{\mu}_a,\;{\mu}_t)$. Flocculation is an important step in many solid-liquid separation processes and is widely used. When two particles approach each other, interactions of several colloid particles can come into play which may have major effect on the flocculation and LIF process, The value of scattering coefficient ${\mu}_s$ is large by means of the increasing particles of scatterer it has been found that the slope decays exponentially as a function of distance from laser source to detector. It may also aid in designing the best model for oil chemistry, biopharmaceutical products, laser medicine and application of medical engineering on LIF and coagulation in particle transport mode.

• Journal of mucopolysaccharidosis and rare diseases
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• v.1 no.1
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• pp.23-27
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• 2015

Recent research trends of human growth hormone (hGH) are divided into improved first-generation products, long-acting second-generation products, and biosimilar products. Among the improved first-generation products studies, studies of injection devices are being actively conducted. The long-acting second-generation products are focused on extending the half-life of hGH, and depending on the results of the clinical trials, the candidates are expected to lead the future hGH market. Finally, biosimilar has had less impact on the hGH market before now; however, expectations of low-cost products still remainas an opportunity.

• Membrane Journal
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• v.30 no.1
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• pp.9-20
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• 2020

Membranes are used in most processes of biopharmaceutical production. It is used for pretreatment of other processes, separation of impurities in the process, virus removal, control of products concentration and buffer solution exchange. Virus filters play an important role in ensuring product efficacy and stability because viral contamination of biopharmaceuticals for humans is a sensitive issue that is directly related to serious clinical outcomes. Virus filters typically have complex multilayer structures made of various polymers such as surface-modified PVDF, PES, CRC. Depending on the manufacturer, filters have different pore structures and shapes, such as symmetric or asymmetric, and is used in the form of pleated membrane, flat sheets or hollow fibers. Virus filters are exclusively supplied by few foreign companies such as Asahi Kasei, Millipore, Pall and Sartorius. Replacing virus filters can be time consuming and expensive, including approval from regulatory agencies through validation. As localization has become important due to Japan's recent export regulations, it is necessary to increase the degree of technical independence.

• The Journal of Bigdata
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• v.9 no.1
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• pp.141-152
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• 2024

In the biopharmaceutical contract manufacturing organization (CMO) business, establishing a production schedule that satisfies the due date for various customer orders is crucial for competitiveness. In a CMO process, each order consists of multiple batches that can be allocated to multiple production lines in small batch units for parallel production. This study proposes a meta-heuristic algorithm to establish a scheduling plan that minimizes the total delivery delay of orders in a CMO process with identical parallel machine. Inspired by biological evolution, the proposed algorithm generates random data structures similar to chromosomes to solve specific problems and effectively explores various solutions through operations such as crossover and mutation. Based on real-world data provided by a domestic CMO company, computer experiments were conducted to verify that the proposed algorithm produces superior scheduling plans compared to expert algorithms used by the company and commercial optimization packages, within a reasonable computation time.

• The Korean Journal of Applied Statistics
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• v.25 no.1
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• pp.125-138
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• 2012

Recent assessments of the biosimilarity of biologic products have received considerable global attention. A clinical trial should be conducted to assess the biosimilarity of a biosimilar product and a innovator biological product. In this paper we will describe several methods for the implementation of clinical trials and statistical analysis, a real international case and related international guidelines.

• Journal of Pharmaceutical Investigation
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• v.39 no.4
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• pp.263-267
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• 2009

The purpose of this study is to evaluate the efficacy of stipulated cleaning process, and the prohibition of cross-contamination and microbiological contamination, which inadequate cleaning in multi-production could occur, through cleaning validation of multi-purpose facility used to produce five biopharmaceutical products as sterile injection. After production of five biopharmaceutical products such as hGH, rhGCSF, rhEPO, rhFSH and rhIFN using vial filling machine, the cleaning validation such as residual analysis of active ingredients or human serum albumin, measurement of total organic carbon (TOC), residual analysis of detergent and microbiological contamination were carried out. In the case of rhGH and rhGCSF clean validations, drug residues were not detected. Furthermore, in the case of rhEPO, rhFSH and rhIFN clean validations, human serum albumin residues were not detected. At TOC (total organic carbon) analysis, all clean validations gave the TOC of about average 137.93%, not more than 150% of acceptance criteria. At sodium analysis for the checking of residues of cleaning agent, sodium residues were not detected. In sterility test, they showed no microbiological contamination of bacteria and fungi. Thus, this cleaning validation was determined as successful in protection of cross-contamination and induction of safety in multi-purpose facility.