• Proceedings of the PSK Conference
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• 2002.10a
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• pp.309.1-309.1
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• 2002

Ginsan, a polysaccharide extracted from Panax ginseng. was earlier scrutinized for a biological-response modifier. We further studied the protective and restorative activity of Ginsan against sublethal dose irradiation owing to increase production of endogenous hematopoietic growth factors such as IL-1. TNF-${\alpha}$. IL-6, GM-CSF. Which induce strong redox-emzyme elevation. Exposing to radiation induces reactive oxygen species (ROS). which play an important causative role in radiation damage. (omitted)

• 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.

• 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.

• Journal of Microbiology and Biotechnology
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• v.32 no.6
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• pp.681-698
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• 2022

The Nile tilapia Oreochromis niloticus, Atlantic salmon Salmo salar, rainbow trout Oncorhynchus mykiss, olive flounder Paralichthys olivaceus, common carp Cyprinus carpio, grass carp Ctenopharyngodon idella and rohu carp Labeo rohita are farmed commercially worldwide. Production of these important finfishes is rapidly expanding, and intensive culture practices can lead to stress in fish, often reducing resistance to infectious diseases. Antibiotics and other drugs are routinely used for the treatment of diseases and sometimes applied preventatively to combat microbial pathogens. This strategy is responsible for the emergence and spread of antimicrobial resistance, mass killing of environmental/beneficial bacteria, and residual effects in humans. As an alternative, the administration of probiotics has gained acceptance for disease control in aquaculture. Probiotics have been found to improve growth, feed utilization, immunological status, disease resistance, and to promote transcriptomic profiles and internal microbial balance of host organisms. The present review discusses the effects of single and multi-strain probiotics on growth, immunity, heamato-biochemical parameters, and disease resistance of the above-mentioned finfishes. The application and outcome of probiotics in the field or open pond system, gaps in existing knowledge, and issues worthy of further research are also highlighted.

• IMMUNE NETWORK
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• v.4 no.2
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• pp.94-99
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• 2004

Background: We previously reported that ginsan, a polysaccharide extracted from Panax ginseng had an immunostimulatory activity such as mitogenic activity, activation of macrophages and killer cells, and production of a variety of cytokines which resulted in antitumor and antiseptic effects. We further purified $\alpha$-(1$\longrightarrow$6)-glucan and $\beta$-(2$\longrightarrow$6)-fructan from the ginsan with size exclusion and ion-exchange column chromatography successively. In this study, we performed the structure-based activity of ginsan by comparison with known polysacchrides such as $\beta$-glucan, curdlan, laminarin, levan, dextran, lentinan and OK-432. Methods: To investigate the immunostimulatory activity of several polysaccharide compounds, we investigated the stimulation of lymphocytes proliferation, the generation of activated killer cells and the secretion of nitrites from activated macrophages. Results: Of polysaccharides tested, curdlan and ginsan stimulated lymphocyte proliferation, suggesting that the molecular weight and composition of polysaccharide are dependent on the mitogenic activity. The production of nitric oxide was significantly increased in curdlan, levan, ginsan and its fraction, indicating that fructan has also capacity to activate macrophages and may devote to kill pathogens. In addition, the activation of macrophages was seemed to be independent of molecular weight of polysaccharide. The generation of AK cells was exhibited in order of curdlan, OK-432> F1, ginsan, F3> levan> etc. The AK activity may be dependent on molecular weight and composition of polysaccharides. Conclusion: Unfortunately, purified polysaccharide from ginsan were less active on immunostimulatory activity than mixed compounds of polysaccharides. From the viewpoint of structure and activity relationships, we found several characteristic features.

• 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.

• Journal of Microbiology and Biotechnology
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• v.32 no.2
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• pp.238-247
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• 2022

Since the skin covers most surfaces of the body, it is susceptible to damage, which can be fatal depending on the degree of injury to the skin because it defends against external attack and protects internal structures. Various types of artificial skin are being studied for transplantation to repair damaged skin, and recently, the production of replaceable skin using three-dimensional (3D) bioprinting technology has also been investigated. In this study, skin tissue was produced using a 3D bioprinter with human skin cell lines and cells extracted from mouse skin, and the printing conditions were optimized. Gelatin was used as a bioink, and fibrinogen and alginate were used for tissue hardening after printing. Printed skin tissue maintained a survival rate of 90% or more when cultured for 14 days. Culture conditions were established using 8 mM calcium chloride treatment and the skin tissue was exposed to air to optimize epidermal cell differentiation. The skin tissue was cultured for 14 days after differentiation induction by this optimized culture method, and immunofluorescent staining was performed using epidermal cell differentiation markers to investigate whether the epidermal cells had differentiated. After differentiation, loricrin, which is normally found in terminally differentiated epidermal cells, was observed in the cells at the tip of the epidermal layer, and cytokeratin 14 was expressed in the lower cells of the epidermis layer. Collectively, this study may provide optimized conditions for bioprinting and keratinization for three-dimensional skin production.

• Journal of Microbiology and Biotechnology
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• v.31 no.3
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• pp.349-357
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• 2021

Monoclonal antibodies are widely used as diagnostic reagents and for therapeutic purposes, and their demand is increasing extensively. To produce these proteins in sufficient quantities for commercial use, it is necessary to raise the output by scaling up the production processes. This review describes recent trends in high-density cell culture systems established for monoclonal antibody production that are excellent methods to scale up from the lab-scale cell culture. Among the reactors, hollow fiber bioreactors contribute to a major part of high-density cell culture as they can provide a tremendous amount of surface area in a small volume for cell growth. As an alternative to hollow fiber reactors, a novel disposable bioreactor has been developed, which consists of a polymer-based supermacroporous material, cryogel, as a matrix for cell growth. Packed bed systems and disposable wave bioreactors have also been introduced for high cell density culture. These developments in high-density cell culture systems have led to the monoclonal antibody production in an economically favourable manner and made monoclonal antibodies one of the dominant therapeutic and diagnostic proteins in biopharmaceutical industry.

• Molecules and Cells
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• v.25 no.4
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• pp.494-503
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• 2008

Many therapeutic glycoproteins have been successfully generated in plants. Plants have advantages regarding practical and economic concerns, and safety of protein production over other existing systems. However, plants are not ideal expression systems for the production of biopharmaceutical proteins, due to the fact that they are incapable of the authentic human N-glycosylation process. The majority of therapeutic proteins are glycoproteins which harbor N-glycans, which are often essential for their stability, folding, and biological activity. Thus, several glyco-engineering strategies have emerged for the tailor-making of N-glycosylation in plants, including glycoprotein subcellular targeting, the inhibition of plant specific glycosyltranferases, or the addition of human specific glycosyltransferases. This article focuses on plant N-glycosylation structure, glycosylation variation in plant cell, plant expression system of glycoproteins, and impact of glycosylation on immunological function. Furthermore, plant glyco-engineering techniques currently being developed to overcome the limitations of plant expression systems in the production of therapeutic glycoproteins will be discussed in this review.

• BMB Reports
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• v.51 no.2
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• pp.85-91
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• 2018

Pluripotent stem cell (PSC) variations can cause significant differences in the efficiency of cardiac differentiation. This process is unpredictable, as there is not an adequate indicator at the undifferentiated stage of the PSCs. We compared global gene expression profiles of two PSCs showing significant differences in cardiac differentiation potential. We identified 12 up-regulated genes related to heart development, and we found that 4 genes interacted with multiple genes. Among these genes, Gata6 is the only gene that was significantly induced at the early stage of differentiation of PSCs to cardiomyocytes. Gata6 knock-down in PSCs decreased the efficiency of cardiomyocyte production. In addition, we analyzed 6 mESC lines and 3 iPSC lines and confirmed that a positive correlation exists between Gata6 levels and efficiency of differentiation into cardiomyocytes. In conclusion, Gata6 could be utilized as a biomarker to select the best PSC lines to produce PSC-derived cardiomyocytes for therapeutic purposes.