Characterization of Biopharmaceuticals Focusing on Antibody Therapeutics

Biopharmaceuticals are highly complex molecules and also require high quality for safety and efficacy in human uses. For well-characterized products, the desired level of quality should be monitored and controlled during the manufacturing processes. A series of workflow for analytical characterization should be applied for product quality throughout those processes. In this chapter, several analytical techniques are introduced for assessing characteristics of biopharmaceuticals focusing on monoclonal antibodies (mAbs). Analytical characterization for primary structure was performed by mass spectrometry (MS), and assessment of post-translational modifications (PTMs) was done by conventional approaches. The analytical assessments were also done by multi-attribute method (MAM) approach using mass spectrometer (MS), and the performance of MAM was compared to conventional approaches

Reproductive and Hormonal Factors Associated with Fatty or Dense Breast Patterns among Korean Women

PURPOSE: Dense breasts have been suggested as a risk factor for breast cancer, but controversy still remains. This study evaluates the association of reproductive and hormonal factors with dense breasts among Korean women. MATERIALS AND METHODS: Using a cross-sectional design, 516 women were recruited and classified for breast density patterns as being either fatty or dense, using the Breast Imaging Reporting and Data System (BI-RADS) of the American College of Radiology. Univariate and multivariate logistic regression models were used for statistical analysis. RESULTS: In univariate logistic regression, older age, higher body mass index, older age at menarche, and oral contraceptive use were associated with more fatty breasts. On the contrary, longer duration of education, alcohol consumption, lower parity, menopause and use of hormone replacement therapy were associated with dense breasts. After adjustment, age and body mass index were inversely associated with breast density (p-value for trend <0.01, respectively), whereas nulliparous and premenopausal status were positively associated. Compared to women who had ≥2 children, nulliparous women had an 11.8-fold increase of dense breasts (p-value for trend <0.01). Compared to postmenopausal women, premenopausal women had 2.4-fold increase of dense breasts (odds ratio, 2.42; 95% confidence interval, 1.36 to 4.32). CONCLUSION: Young age, lower body mass index, lower parity, and premenopausal status were significantly associated with dense breasts in Koreaope

A Case of Cutaneous Bronchogenic Cyst Presenting with Lymphoid Follicles

Cutaneous bronchogenic cysts are rare, and stem from developmental abnormalities of the tracheobronchial tree. The condition is often misdiagnosed clinically, with the correct diagnosis usually established by histopathologic examination. Published reports of bronchogenic or branchial anomalies are increasing, and the traditional defining characteristics of location and histopathology are proving to be less reliable for the identification of cutaneous bronchogenic cysts. In this report, we describe a case of a cutaneous bronchogenic cyst that presented with unusual histologic features, and was associated with several lymphoid follicles

Effect of a Combination of Low Level Ozone and Metal Ions on Reducing Escherichia coli O157:H7 and Listeria monocytogenes

Ozonated water has been used as a strong antimicrobial agent against foodborne pathogens. In this study, the combined effect of low level ozonated water and different added components, including 0.2% starch and metal ions (1 mM CuCl2·2H2O and 0.1 mM AgNO3), on inactivation of Escherichia coli O157:H7 and Listeria monocytogenes was investigated. Treatment with 0.4 ppm ozonated water for 30 min resulted in a maximum log reduction in E. coli O157:H7 and L. monocytogenes compared to initial bacterial counts. The log reductions of bacteria in a starch solution containing ozonated water were slightly higher than those in ozonated water alone. Furthermore, the log reductions of E. coli O157:H7 (2.59 and 4.71 log cfu/mL) and L. monocytogenes (2.53 and 4.28 log cfu/mL) in a metal ion solution containing 0.2 and 0.4 ppm ozone for 30 min were significantly higher than those of the water and starch added groups (p < 0.05). These results indicate that a combination of ozonated water and metal ions may be useful as a antimicrobial agent

Effect of a Combination of Low Level Ozone and Metal Ions on Reducing Escherichia coli O157:H7 and Listeria monocytogenes

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Mycophenolate Antagonizes IFN-γ-Induced Catagen-Like Changes via β-Catenin Activation in Human Dermal Papilla Cells and Hair Follicles

Recently, various immunosuppressant drugs have been shown to induce hair growth in normal hair as well as in alopecia areata and androgenic alopecia; however, the responsible mechanism has not yet been fully elucidated. In this study, we investigate the influence of mycophenolate (MPA), an immunosuppressant, on the proliferation of human dermal papilla cells (hDPCs) and on the growth of human hair follicles following catagen induction with interferon (IFN)-γ. IFN-γ was found to reduce β-catenin, an activator of hair follicle growth, and activate glycogen synthase kinase (GSK)-3β, and enhance expression of the Wnt inhibitor DKK-1 and catagen inducer transforming growth factor (TGF)-β2. IFN-γ inhibited expression of ALP and other dermal papillar cells (DPCs) markers such as Axin2, IGF-1, and FGF 7 and 10. MPA increased β-catenin in IFN-γ-treated hDPCs leading to its nuclear accumulation via inhibition of GSK3β and reduction of DKK-1. Furthermore, MPA significantly increased expression of ALP and other DPC marker genes but inhibited expression of TGF-β2. Therefore, we demonstrate for the first time that IFN-γ induces catagen-like changes in hDPCs and in hair follicles via inhibition of Wnt/β-catenin signaling, and that MPA stabilizes β-catenin by inhibiting GSK3β leading to increased β-catenin target gene and DP signature gene expression, which may, in part, counteract IFN-γ-induced catagen in hDPCs