• 중국학논총
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• no.68
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• pp.163-189
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• 2020

最近在世界医药市场, 新药研究开发能力卓越的美国和欧洲国际制药公司正在抢占先机的情况下, 韩国, 中国, 印度等亚洲国家为了发展蓝海的医药产业, 正在从政策上给予支持。 目前中国的医药市场规模为14亿庞大人口, 继美国之后居世界第二位, 但与医药企业销售额相比,R&D经费支出比重较低, 与全球制药企业相差甚远, 国际竞争力也较低, 主要出口医药原料品, 醫藥制成品主要依赖进口。但是最近中国政府积极推进医药产业结构调整和生物医药产业培育战略, 因此有必要关注中国医药产业的发展趋势。 本文首先对中国医药产业的发展现状和结构变化, 国际竞争力变化进行详细分析, 然后指出医药产业面临的课题, 加以分析. 最後从总体上来看,给予我们的启示是什么.

• Journal of Microbiology and Biotechnology
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• v.25 no.7
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• pp.953-962
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• 2015

Escherichia coli is the most preferred microorganism to express heterologous proteins for therapeutic use, as around 30% of the approved therapeutic proteins are currently being produced using it as a host. Owing to its rapid growth, high yield of the product, costeffectiveness, and easy scale-up process, E. coli is an expression host of choice in the biotechnology industry for large-scale production of proteins, particularly non-glycosylated proteins, for therapeutic use. The availability of various E. coli expression vectors and strains, relatively easy protein folding mechanisms, and bioprocess technologies, makes it very attractive for industrial applications. However, the codon usage in E. coli and the absence of post-translational modifications, such as glycosylation, phosphorylation, and proteolytic processing, limit its use for the production of slightly complex recombinant biopharmaceuticals. Several new technological advancements in the E. coli expression system to meet the biotechnology industry requirements have been made, such as novel engineered strains, genetically modifying E. coli to possess capability to glycosylate heterologous proteins and express complex proteins, including full-length glycosylated antibodies. This review summarizes the recent advancements that may further expand the use of the E. coli expression system to produce more complex and also glycosylated proteins for therapeutic use in the future.

• Molecules and Cells
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• v.47 no.1
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• pp.100005.1-100005.15
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• 2024

Amyotrophic lateral sclerosis is a devastating neurodegenerative disease with a complex genetic basis, presenting both in familial and sporadic forms. The hexanucleotide (G₄C₂) repeat expansion in the C9orf72 gene, which triggers distinct pathogenic mechanisms, has been identified as a major contributor to familial and sporadic Amyotrophic lateral sclerosis cases. Animal models have proven pivotal in understanding these mechanisms; however, discrepancies between models due to variable transgene sequence, expression levels, and toxicity profiles complicate the translation of findings. Herein, we provide a systematic comparison of 7 publicly available Drosophila transgenes modeling the G₄C₂ expansion under uniform conditions, evaluating variations in their toxicity profiles. Further, we tested 3 previously characterized disease-modifying drugs in selected lines to uncover discrepancies among the tested strains. Our study not only deepens our understanding of the C9orf72 G₄C₂ mutations but also presents a framework for comparing constructs with minute structural differences. This work may be used to inform experimental designs to better model disease mechanisms and help guide the development of targeted interventions for neurodegenerative diseases, thus bridging the gap between model-based research and therapeutic application.

• Journal of Plant Biotechnology
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• v.36 no.4
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• pp.309-319
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• 2009

Transgenic plant cell cultures for the production of biopharmaceuticals including monoclonal antibodies, recombinant proteins have been regarded as an alternative platform in addition to traditional microbial fermentation and mammalian cell cultures. Plant-made pharmaceuticals (PMPs) have several advantages such as safety, cost-effectiveness, scalability and possibility of complex post-translational modifications. Increasing demand for the quantity and diversity of pharmaceutical proteins may accelerate the industrialization of PMP technology. Up to date, there is no plant-made recombinant protein approved by USFDA (Food and Drug Administration) for human therapeutic uses due to the technological bottlenecks of low expression level and slight differences in glycosylation. Regarding expression levels, it is possible to improve the productivity by using stronger promoter and optimizing culture processes. In terms of glycosylation, humanization has been attempted in many ways to reduce immune responses and to enhance the efficacy as well as stability. In this review article, all these respects of transgenic plant cell cultures were summarized. In addition, we also discuss the general characteristics of plant cell suspension cultures related with bioreactor design and operation to achieve high productivity in large scale which could be a key to successful commercialization of PMPs.

• Microbiology and Biotechnology Letters
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• v.36 no.1
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• pp.12-20
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• 2008

Validation of viral safety is essential in ensuring the safety of mammalian cell culture-derived biopharmaceuticals, because numerous adventitious viruses have been contaminated during the manufacture of the products. Mammalian cells are highly susceptible to minute virus of mice(MVM), and there are several reports of MVM contamination during the manufacture of biopharmaceuticals. In order to establish the validation system for the MVM safety, a real-time PCR method was developed for quantitative detection of MVM in cell lines, raw materials, manufacturing processes, and final products as well as MVM clearance validation. Specific primers for amplification of MVM DNA was selected, and MVM DNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be $6{\times}10^{-2}TCID_{50}/mL$. The real-time PCR method was proven to be reproducible and very specific to MVM. The established real-time PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with MVM. MVM DNA could be Quantified in CHO cell as well as culture supernatant. When the real-time PCR assay was applied to the validation of virus removal during a virus filtration process, the result was similar to that of virus infectivity assay. Therefore, it was concluded that this rapid, specific, sensitive, and robust assay could replace infectivity assay for detection and clearance validation of MVM.

• Journal of Korea Port Economic Association
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• v.34 no.3
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• pp.1-16
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• 2018

The demand for biopharmaceuticals is on the rise spurred by the fourth industrial revolution and an aging society in Korea. Consequently, the scale of the biopharmaceutical industry is continuously increasing globally, thereby leading to an increase in the distribution of biopharmaceuticals. However, the relative inferiority of the domestic drug distribution structure, when compared to the advanced countries, and strict logistics regulations concerning the handling of biopharmaceuticals have raised the need for systematic management. Essentially, the significance of third-party logistics companies in the cold chain for pharmaceutical cold chain has increased with an intense management environment for pharmaceuticals. The purpose of this study is to investigate the selection factors of drug cold chain's third-party logistics companies and to examine the influence of selection factors on satisfaction. A multiple regression analysis was conducted to investigate how cold chain third-party logistics factors affect the satisfaction of third-party logistics in cold chain. The results of analysis showed that expertise, facility, and linkage are factors affect customer satisfaction. The managerial capacity was derived not as an influential factor. These findings suggest that the future cold chain industry will be equipped to provide direction and strategic implications.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.21-21
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• 2003

BT(Biotechnology) is transition stage from study and technology to mass production and one of most promising part in leading industry. After early completion of genome project, many countries keep trying their best to preoccupy in this field. Korean government support BT more than 10 years. Because their eco-compatibility and cleanness, BT is very promising part. But the big issue is the morals of genetic manipulation. (omitted)

• Molecules and Cells
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• v.20 no.1
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• pp.83-89
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• 2005

HtrA2/Omi is a mammalian mitochondrial serine protease homologous to the E. coli HtrA/DegP gene products. Recently, HtrA2/Omi was found to have a dual role in mammalian cells, acting as an apoptosis-inducing protein and being involved in maintenance of mitochondrial homeostasis. By screening a human brain cDNA library with $A{\beta}$ peptide as bait in a yeast two-hybrid system, we identified HtrA2/Omi as a binding partner of $A{\beta}$ peptide. The interaction between $A{\beta}$ peptide and HtrA2/Omi was confirmed by an immunoblot binding assay. The possible involvement of HtrA2/Omi in $A{\beta}$ peptide metabolism was investigated. In vitro peptide cleavage assays showed that HtrA2/Omi did not directly promote the production of $A{\beta}$ peptide at the ${\beta}/{\gamma}$-secretase level, or the degradation of $A{\beta}$ peptide. However, overexpression of HtrA2/Omi in K269 cells decreased the production of $A{\beta}40$ and $A{\beta}42$ by up to 30%. These results rule out the involvement of HtrA2/Omi in the etiology of Alzheimer's disease. However, the fact that overexpression of HtrA2/Omi reduces the generation of $A{\beta}40$ and $A{\beta}42$ suggests that it may play some positive role in mammalian cells.

• 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.

• Microbiology and Biotechnology Letters
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• v.51 no.3
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• pp.223-242
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• 2023

In contrast to chemical medicines, biopharmaceuticals exhibit reduced side effects and enhanced therapeutic efficacy. Antibody therapies have significantly advanced since the first monoclonal antibody's approval in 1986, now dominating the pharmaceutical market with seven out of the top 10 biopharmaceuticals. The bispecific antibody has a distinct capability to bind to two antigens simultaneously, unlike conventional monoclonal antibodies that target just one antigen. The notion of bispecific antibodies was initially introduced in 1960, and by 1997, the first symmetrical form of bispecific antibody was successfully produced. Subsequently, extensive research has been conducted on bispecific antibodies, leading to a significant milestone in 2014 when blinatumomab became the first FDA-approved drug to treat acute lymphocytic leukemia. Despite having a relatively shorter history compared to monoclonal antibodies, bispecific antibodies have proven their potential by targeting two antigens simultaneously, thereby rendering them highly effective as anti-cancer drugs. As of 2023, there are a total of 11 globally approved bispecific antibodies, with six of them receiving approval from FDA. In light of the rapidly expanding market for bispecific antibodies, this review article comprehensively explores the attributes, historical background, applications, and market status of bispecific antibodies. Additionally, it sheds light on the present trends in bispecific antibody development, drawing insights from 96 research articles and 105 clinical studies. Excitingly, we anticipate further progress in the development of bispecific antibodies and clinical trials on a global scale, with the aspiration of utilizing them not only in cancer treatment but also for addressing diverse medical conditions.