• Microbiology and Biotechnology Letters
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• v.36 no.1
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• pp.34-42
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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 using bovine materials have the risk of viral contamination. Therefore viral validation is essential in ensuring the safety of the products. Bovine viral diarrhoea virus (BVDV) is the most common bovine pathogen and has widely been known as a contaminant of biologics. In order to establish the validation system for the BVDV safety of biologics, a real-time RT-PCR method was developed for quantitative detection of BVDV contamination in raw materials, manufacturing processes, and final products. Specific primers for amplification of BVDV RNA was selected, and BVDV RNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be 1 $TCID_{50}/mL$. The rent-time RT-PCR method was validated to be reproducible and very specific to BVDV. The established real-time RT-PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BVDV. BVDV RNA could be quantified in CHO cell as well as culture supernatant. Also the real-time RT-PCR assay could detect $10TCID_{50}/mL$ of BVDV artificially contaminated in bovine collagen.

• Proceedings of the PSK Conference
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• 2004.10a
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• pp.141-141
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• 2004

• Proceedings of the PSK Conference
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• 2005.04a
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• pp.122-123
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• 2005

• Proceedings of the PSK Conference
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• 2005.11a
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• pp.157-157
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• 2005

• Proceedings of the PSK Conference
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• 2005.11a
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• pp.160-160
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• 2005

• Proceedings of the PSK Conference
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• 2001.04a
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• pp.245.1-245.1
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• 2001

• BMB Reports
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• v.55 no.1
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• pp.1-2
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• 2022

• Journal of mucopolysaccharidosis and rare diseases
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• v.1 no.1
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• pp.28-30
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• 2015

Biologics present a challenge to both the manufacturer and end user. They must usually be formulated as parenterals. However, they are often unstable in liquid form, due to their complex structure and composition. In that case, they must be manufactured using highly specialized processes, such as lyophilization (freeze-drying). Lyophilization nearly eliminates stability issues. Reducing a compound's sensitivity to temperature prolongs its shelf life. However, reconstitution can be cumbersome, involving multiple steps that increase the potential for error. Dual-chamber technology provides an effective alternative, combining a lyophilized drug and diluent in a closed system and enabling reconstitution in a few simple steps.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.22 no.1
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• pp.50-56
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• 2019

The incidence of pediatric inflammatory bowel disease (IBD) is increasing worldwide, especially in the developing countries. It differs from adult disease in clinical manifestations, especially with regard to genetic predisposition in monogenic IBD. Pediatric disease also have a tendency to show more aggressive inflammation and greater extent of lesion. Newer drugs such as anti-tumor necrosis factor ${\alpha}$ have been known to make a difference in treating pediatric IBD. Recent studies suggested that the patients with high risk factors might have some benefits from earlier use of biologics. To achieve treatment goals such as relieving symptoms, optimizing growth, and improving quality of life while minimizing drug toxicity, more research is needed to develop tools for risk stratification in the use of biologics for pediatric IBD.

• Tuberculosis and Respiratory Diseases
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• v.85 no.4
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• pp.283-288
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• 2022

Asthma is a chronic inflammatory disease of the airways characterized by varying and recurrent symptoms, reversible airway obstruction, and bronchospasm. In this paper, clinical important studies on asthma published between March 2021 and February 2022 were reviewed. A study on the relationship between asthma and chronic rhinosinusitis, bronchiectasis, and hormone replacement therapy was published. A journal on the usefulness of fractional exhaled nitric oxide for the prediction of severe acute exacerbation was also introduced. Studies on the effect of inhaler, one of the most important treatments for asthma, were published. Studies on the control of severe asthma continued. Phase 2 and 3 studies of new biologics were also published. As the coronavirus disease 2019 (COVID-19) pandemic has been prolonged, many studies have explored the prevalence and mortality of COVID-19 infection in asthma patients.