Characterization and Value Assignment of a Monoclonal Antibody Reference Material, NMIJ RM 6208a, AIST-MAB.

Monoclonal antibodies have been established as the largest product class of biopharmaceuticals. Since extensive characterization is required for development and quality control of monoclonal antibody, a widely available reference material (RM) is needed. Herein, a humanized IgG1κ monoclonal antibody reference material, RM 6208-a, AIST-MAB, was established by the National Metrology Institute of Japan, National Institute of Advanced Industrial Science and Technology (NMIJ/AIST). The monoclonal antibody solution was produced as a pharmaceutical grade using a Chinese hamster ovary-derived cell line. The assigned indicative value represents the concentration of the antibody with a heterotetrameric structure including oligomeric forms, determined by an amino acid analysis using isotope dilution mass spectrometry, and their homogeneity and stability were assessed. In addition to antibody concentration, various physicochemical properties, including peptide mapping data, charge variants, and aggregates, were examined. This RM is intended for use in validation of analytical procedures and instruments such as a system suitability test for quantification of antibody. It is also intended for comparing and evaluating the results of antibody analyses across analytical methods and analytical laboratories such as inter-laboratory comparison. Both the material and the set of data from our study provide a tool for an accurate and reliable characterization of product quality attributes of monoclonal antibodies in biopharmaceutical and metrology communities.

Establishment of reference costs for occupational health services and implementation of cost management in Japanese manufacturing companies.

OBJECTIVES: We developed a standardized cost estimation method for occupational health (OH) services. The purpose of this study was to set reference OH services costs and to conduct OH services cost management assessments in two workplaces by comparing actual OH services costs with the reference costs. METHODS: Data were obtained from retrospective analyses of OH services costs regarding 15 OH activities over a 1-year period in three manufacturing workplaces. We set the reference OH services costs in one of the three locations and compared OH services costs of each of the two other workplaces with the reference costs. RESULTS: The total reference OH services cost was 176,654 Japanese yen (JPY) per employee. The personnel cost for OH staff to conduct OH services was JPY 47,993, and the personnel cost for non-OH staff was JPY 38,699. The personnel cost for receipt of OH services-opportunity cost-was JPY 19,747, expense was JPY 25,512, depreciation expense was 34,849, and outsourcing cost was JPY 9,854. We compared actual OH services costs from two workplaces (the total OH services costs were JPY 182,151 and JPY 238,023) with the reference costs according to OH activity. The actual costs were different from the reference costs, especially in the case of personnel cost for non-OH staff, expense, and depreciation expense. CONCLUSIONS: Using our cost estimation tool, it is helpful to compare actual OH services cost data with reference cost data. The outcomes help employers make informed decisions regarding investment in OH services.

Development of cost estimation tools for total occupational safety and health activities and occupational health services: cost estimation from a corporate perspective.

OBJECTIVES: The aim of the present study was to develop standardized cost estimation tools that provide information to employers about occupational safety and health (OSH) activities for effective and efficient decision making in Japanese companies. METHODS: We interviewed OSH staff members including full-time professional occupational physicians to list all OSH activities. Using activity-based costing, cost data were obtained from retrospective analyses of occupational safety and health costs over a 1-year period in three manufacturing workplaces and were obtained from retrospective analyses of occupational health services costs in four manufacturing workplaces. We verified the tools additionally in four workplaces including service businesses. RESULTS: We created the OSH and occupational health standardized cost estimation tools. OSH costs consisted of personnel costs, expenses, outsourcing costs and investments for 15 OSH activities. The tools provided accurate, relevant information on OSH activities and occupational health services. CONCLUSIONS: The standardized information obtained from our OSH and occupational health cost estimation tools can be used to manage OSH costs, make comparisons of OSH costs between companies and organizations and help occupational health physicians and employers to determine the best course of action.

Efficacy of cognitive behavioral therapy training using brief e-mail sessions in the workplace: a controlled clinical trial.

In the present study, we conducted a clinical controlled trial to evaluate the effects of cognitive behavioral therapy (CBT) training in improving depression and self-esteem in workers. A total of 261 workers were assigned to either an intervention group (n=137) or a waiting-list group (n=124). The intervention group was offered participation in a group session with CBT specialists and three e-mail sessions with occupational health care staff. Between-group differences in the change in Center for Epidemiologic Studies Depression Scale (CES-D) and Self-Esteem Scale from baseline to three months after the end of training were assessed by analysis of covariance. All subjects in the intervention group completed the group session and 114 (83%) completed the three e-mail sessions. CES-D score decreased by 2.21 points in the intervention group but increased by 0.12 points in the control group, a significant difference of -2.33 points (95% confidence interval: -3.89 to-0.77; p<0.001). The between-group difference in change of self-esteem scores was not significant. Results of the present study suggest that CBT training cooperatively provided by CBT specialists and occupational health care staff using brief e-mail is effective in improving feelings of depression in workers.

Effect of brief sleep hygiene education for workers of an information technology company.

To investigate the effects of sleep hygiene education for workers of an information technology (IT) company, we conducted a controlled clinical trial providing 581 workers one-hour sleep hygiene education. The contents of the sleep hygiene education program were a review of sleep habits, provide sleep hygiene education, and the establishment of sleep habit goals. A self-report questionnaire was used to measure outcomes including the Pittsburgh Sleep Quality Index (PSQI), Karolinska Sleepiness Scale (KSS), Checklist Individual Strength (CIS), Center for Epidemiologic Studies for Depression (CES-D), and mean sleep duration on weekdays before and 4 wk after the intervention. A total of 391 participants were included in the analysis, with 214 participants in the sleep hygiene education group and 177 in the waiting list group. KSS score at 2 P.M. decreased by 0.42 points in the sleep hygiene education group, but increased by 0.08 points in the waiting list group, showing a significant effect size of 0.50 (95%CI, -0.97 to -0.04, p<0.05). PSQI score also improved, but the inter-group difference was not statically significant. The present study provides preliminary evidence that brief sleep hygiene education may improve afternoon sleepiness at work, but not sleep at night for IT workers.

Development and validity of the Japanese version of the organizational justice scale.

Organizational justice has recently attracted attention as a predictor of employee mental and physical health. However, the lack of a Japanese translation of the original English-language organizational justice scale (OJS) has precluded its application in Japan. The present study aimed to develop Japanese version of the measure of organizational justice. We translated the original questionnaire, which is comprised of 20 items, from English to Japanese. The OJS is made up of four distinct dimensions: procedural, distributive, interpersonal and information justice. A total of 229 employees responded to the Japanese version of the OJS (OJS-J), the effort-reward imbalance (ERI) model and the Kessler Psychological Distress Scale (K10). To assess construct validity, we recorded job satisfaction using the visual analog scale (VAS). Our exploratory factor analysis supported the four-factor structure model of OJS-J. Correlation coefficients between the OJS-J and ERI, K10 and VAS were statistically significant, indicating a reasonable degree of construct validity. Obtained internal consistency was markedly high (Cronbach's alpha was 0.96), and test-retest reliability as analyzed with an intraclass correlation coefficient was 0.91. These results suggest that the OJS-J is a reliable and valid measure that may be suitable for use as a predictor of employee health in the Japanese work place.

Sleep-disordered breathing and hypertension in Japanese steel workers.

Sleep-disordered breathing (SDB) is the major determinants of hypertension. Recent studies indicated sleep duration, in addition to shift work, were also associated with hypertension. But very little attention has been paid to these two factors when looking at the effects of SDB on blood pressure. We conducted the present study to evaluate the relationship between SDB and hypertension adjusting for sleep duration and shift work in a sample of Japanese steel workers. In this cross-sectional study, we measured blood pressure and oxygen desaturations index (ODI) by nocturnal pulse oximetry of 249 male workers aged 20 to 65 yr. SDB was defined by 3%ODI level of 15 or more events per hour. Logistic regression analyses were performed to estimate the associations of SDB with hypertension after adjustment for age, body mass index, alcohol intake, smoking, usual sleep duration, shift work, and occupation. The prevalence of SDB was 18.1%. The adjusted odds ratio of hypertension for high (> or =15) vs. low (<15) category of 3%ODI level was 2.86 (95% confidence interval, 1.23-6.66). The significant association between SDB and hypertension suggests that screening for SDB among steel workers is useful for prevention of hypertension.