• KSBB Journal
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• v.29 no.5
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• pp.361-371
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• 2014

Mycoplasma is well recognized as one of the most prevalent and serious microbial contaminants of biologic manufacturing processes. Conventional methods for mycoplasma testing, direct culture method and indirect indicator cell culture method, are lengthy, costly and less sensitive to noncultivable species. In this report, we describe a new TaqMan probe-based real-time PCR method for rapid and quantitative detection of mycoplasma contamination during manufacture of biologics. Universal mycoplasma primers were used for mycoplasma PCR and mycoplasma DNA was quantified by use of a specific TaqMan probe. Specificity, sensitivity, and robustness of the real-time PCR method was validated according to the European Pharmacopoeia. The validation results met required criteria to justify its use as a replacement for the culture method. The established real-time PCR assay was successfully applied to the detection of mycoplasma from human keratinocyte and mesenchymal stem cell as well as Vero cell lines artificially infected with mycoplasma. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of mycoplasma contamination during manufacture of biologics.

• The Journal of the Korean Society for Microbiology
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• v.34 no.6
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• pp.583-589
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• 1999

Acellular pertussis vaccine has been used widely in Korea since 1984. However, because many of the former generations were not inoculated with pertussis vaccine, they may infect infants with pertussis. With this background, we investigated the prevalence of pertussis antibodies in all age groups. Enzyme-linked immunosorbent assay (ELISA) to assess IgG antibodies to pertussis toxin (PT) and filamentous hemagglutinin (FHA) and bacterial agglutination (BA) to assess antibodies to agglutinogen were compared on 842 serum samples which were donated from 11 hospitals in Seoul area. In comparison with age groups under 20 years, antibodies of adults against PT and FHA were maintained. But antibodies against agglutinogen showed no pattern in all age groups. Antibodies to PT were correlated with antibodies to FHA. There was no significant difference in antibody levels between male and female (p<0.05).

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.21 no.1
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• pp.1-11
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• 2018

The emergence of mucosal healing as a treatment goal that could modify the natural course of Crohn's disease and the accumulating evidence showing that biologics are most effective in achieving mucosal healing, along with the success of early treatment regimens for rheumatoid arthritis, have led to the identification of early Crohn's disease and development of the concept of catching the therapeutic window during the early disease course. Thus, an increasing number of pediatric gastroenterologists are adopting an early biologic treatment strategy with or without an immunomodulator. Although early biologic treatment is effective, cost and overtreatment are issues that limit its early use. Currently, there are insufficient data on who will benefit most from early biologics, as well as on who will not need early or even any biologics. For now, top-down biologics should be considered for patients with currently known high-risk factors of poor outcomes. For other patients, close, objective monitoring and accelerating the step-up process by means of a treat-to-target approach seems the best way to catch the therapeutic window in early pediatric Crohn's disease. The individual benefits of immunomodulator addition during early biologic treatment should be weighed against its risks and decision on early combination treatment should be made after comprehensive discussion with each patient and guardian.

• Microbiology and Biotechnology Letters
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• v.36 no.3
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• pp.173-181
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• 2008

Bovine blood, cell, tissue, and organ are used as raw materials for manufacturing biologics such as biopharmaceuticals, tissue-engineered products, and cell therapy. Manufacturing processes for the biologics have the risk of viral contamination. Therefore viral validation is essential in ensuring the safety of the products. Bovine parvovirus (BPV) is one of the common bovine pathogens and has widely been known as a possible contaminant of biologics. In order to establish the validation system for the BPV safety of biologics, a real-time PCR method was developed for quantitative detection of BPV contamination in raw materials, manufacturing processes, and final products. Specific primers for amplification of BPV DNA were selected, and BPV DNA was quantified by use of SYBR Green 1. The sensitivity of the assay was calculated to be $1.3{\times}10^{-1}\;TCID_{50}/mL$. The real-time PCR method was validated to be reproducible and very specific to BPV. The established real-time PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BPV. BPV DNA could be quantified in CHO cell as well as culture supernatant. Also the real-time PCR assay could detect $1.3{\times}10^0\;TCID_{50}/mL$ of BPV artificially contaminated in bovine collagen. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of BPV contamination during manufacture of biologics.

• The Korean Journal of Pesticide Science
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• v.14 no.4
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• pp.421-426
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• 2010

Many bacterial strains inhabit strong saline condition, such as tidal mudflat and salted seafoods, were identified and reported for the proposed protease activities and salt resistance; however antifungal activities against plant fungal pathogen have not well been studied until now. In this study, primary screening was performed for the isolation of promising strains against major plant pathogens like Sclerotinia sclerotiorum, Fusarium oxysporum, Phytophthora capsici, Botrytis cineria, Collectotrichum acutatum and Pythium ultimum. Totally 423 bacterial strain were isolated from laboratory media which was based on different morphological characteristics and all the strains were dual cultured against major fungal pathogens on PDA, finally 40 strains were selected as antifungal bacterial strain and identified by fatty acid phylogenic difference analysis from MIDI shorlock gas chromatography system. As a result, antifungal strains from tidal mudflat were 10 species of 6 genus. Paenibacillus macerans was dominant species; 5 strains among the 17 isolates from tidal mudflat. Antifungal strains from salted seafoods were 7 species of 3 genus and Bacillus atrophaeus was dominant species; 12 strains among the 23 isolates from salted fishes.

• Korean Journal of Veterinary Service
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• v.44 no.3
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• pp.149-155
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• 2021

In virucidal efficacy testing, the chemical inactivation cannot be determined for all viruses due to the difficulties or the inability to culture sufficiently or the risk of exposure to the viruses. Therefore, disinfectants against these viruses could be evaluated by different methods and surrogate viruses are used as alternative. In this study we developed a method for efficacy testing of veterinary disinfectants using one of the candidate surrogate viruses, bacteriophage MS2, as part of the research on the selection of surrogate viruses for efficiency of efficacy testing of veterinary disinfectants. This method is based on the Animal and Plant Quarantine Agency (APQA) guidelines for efficacy testing of veterinary disinfectants. Bacteriophage and disinfectant are reacted in suspension in accordance with the APQA guidelines and then a newly established double agar layer method is applied for the efficacy test. The double agar layer method is summarized as follows: 1) The bottom agar with 1.5% agar is boiled and cooled before poured into petri dishes at volume of 20 mL, and dried under biological safety cabinet. 2) The top agar with 0.7% agar is boiled and kept at 50℃ before E. coli culture was seeded. 3) The serially diluted bacteriophage MS2-disinfectant mixtures 0.05 mL and E. coli host 0.01 mL (OD₆₀₀ 0.2~0.3) are mixed with 5 mL of top agar and incubate them at 50℃ for 5 min for reaction. 4) The resulting mixture is poured over top of a bottom agar plate and rocked sufficiently to ensure that the top agar covers the entire surface of the bottom agar. 5) The double agar layer is then placed under biological safety cabinet to allow the agar layer to solidify and subsequently incubated at 37℃ for 24 hr. 6) Following incubation, the plates may be inspected for plaques and record results.

• Journal of Pharmacopuncture
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• v.19 no.2
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• pp.114-121
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• 2016

Objectives: Lung cancer remains a deadly disease with unsatisfactory overall survival. Cisplatin, a standard platinum (Pt)-based chemotherapeutic agent, has the potential to inhibit the growth of lung cancer. Its use, however, is occasionally limited by severe organ toxicity. However, until now, no systematic study has been conducted to verify its efficacy with proper experimental support in vivo. Therefore, we examined whether biosynthesized Pt nanoparticles (NPs) inhibited human lung cancer in vitro and in vivo to validate their use in alternative and complementary medicine. Methods: We evaluated the in vitro and the in vivo anticancer efficiencies of biosynthesized Pt NPs in a subcutaneous xenograft model with A549 cells. Severe combined immune deficient mice (SCID) were divided into four groups: group 1 being the vehicle control group and groups 2, 3 and 4 being the experimental groups. Once the tumor volume had reached $70-75mm^3$, the progression profile of the tumor growth kinetics and the body weights of the mice were measured every week for 6 weeks after oral administration of Pt NPs. Doses of Pt NPs of 500, 1,000 and 2,000 mg/kg of body weight were administered to the experimental groups and a dose of honey was administered to the vehicle control group. The efficacy was quantified by using the delay in tumor growth following the administration of Pt NPs of A549 human-lung-cancer xenografts growing in SCID mice. Results: The in vitro cytotoxicity evaluation indicated that Pt NPs, in a dose-dependent manner, inhibited the growth of A549 cells, and the in vivo evaluation showed that Pt NPs at the mid and high doses effectively inhibited and delayed the growth of lung cancer in SCID mice. Conclusion: These findings confirm the antitumor properties of biosynthesized Pt NPs and suggest that they may be a cost-effective alternative for the treatment of patients with lung cancer.

• Biomolecules & Therapeutics
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• v.13 no.1
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• pp.59-63
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• 2005

A kinetic assay was carried out in order to compare the ability of detection for prekallikrein activator(PKA) in plasma-derived products with that of an endpoint assay and a commercial method. Using these methods, 9 human albumin preparations were assayed and compared to each other. The coefficient of variation between the Kinetic assay and the end point assay was found within 6.6% and this result showed that two methods were highly correlative and the end point assay could act as a replacement of the kinetic assay. Another important goal of this study was to investigate the reproducibility among laboratories on the kinetic assay. A collaborative study was performed to validate the kinetic method with intra and inter assays. The coefficient of variation for the intra assay of each laboratory was less than 4% and that for between individuals in the inter assay was 4.1%. These results revealed that the kinetic assay showed good reproducibility. The contents of PKA in plasma-derived products were also determined by the kinetic assay. As a result, it was found that trace amounts of PKA were present in 32 human immunoglobulin preparations, however the average concentration of PKA in 171 albumin preparations was 5.8 IU/mL.

• The Korean Journal of Food & Health Convergence
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• v.4 no.3
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• pp.6-11
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• 2018

In the Republic of Belarus as well as in the world acute problem of protecting forests from diseases and pests. The damage caused by root rot is essential, therefore, the problem of forest protection is an urgent task. The biologics has the greatest prospects in according with traditional methods of struggle. Deep method of cultivation of a mushroom Phlebiopsis gigantea with use of nutrient mediums on the basis of ethanol stillage and its components (fugat) is researched. Feasibility of use stillage as raw materials in production of a biological product for the wood protection against root decay is shown. The effect of different additives (sawdust, fodder yeast) on the accumulation of reactive biological product - oidy has been studed It was determined that the deep cultivation using sawdust of the highest accumulation oidy (1.5 $10^6units/ml$). It was also found that the stillage is the best breeding ground for fungus biomass accumulation (7.9 9.8 g / l) versus fugat (6.0 6.6 g / l). On the basis of research work the technological scheme for production of a biological product were developed. Based on the conducted studies, a technological scheme was proposed for obtaining a biological preparation by deep cultivation of the fungus Phlebiopsis gigantea.

• Journal of Korea Society of Digital Industry and Information Management
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• v.19 no.4
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• pp.179-192
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• 2023

ESG is the hottest topic in recent business management or business administration. In particular, with the release of the IPCC's 6th comprehensive report in 2023, environmental issues have been further raised around the world, and ESG management for sustainable and permanent companies is accelerating by improving social and governance structures, including the environment, and thereby enhancing corporate value. This case study is analyzed based on the theory of sustainable growth, creating shared value, and corporate social responsibility. This study focuses on the case of Samsung Biologics, which is pursuing sustainable growth and management through ESG management. Samsung Biologics is the first Korean company to win the "Terra Carta Seal" award, part of a sustainable market initiative to respond to climate change, and externally, it has acquired the Dow Jones Sustainability Index, acquired the KCGS ESG comprehensive evaluation A grade, acquired the CDP B grade, and acquired the EcoVadis Gold grade. It has joined the Sustainable Market Initiative launched by King Charles III since the World Economic Forum in 2020 to chair the Supply Chain. It has joined RE100, TCFD, and UN Global Compact to lead sustainable management through ESG activities. Therefore, we would like to take a practical approach to ESG management strategies for sustainable growth through the example of this company.