| 1. |
- Brinson, Robert G., et al.
(författare)
-
Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics
- 2019
-
Ingår i: mAbs. - : Informa UK Limited. - 1942-0862 .- 1942-0870. ; 11:1, s. 94-105
-
Tidskriftsartikel (refereegranskat)abstract
- The increased interest in using monoclonal antibodies (mAbs) as a platform for biopharmaceuticals has led to the need for new analytical techniques that can precisely assess physicochemical properties of these large and very complex drugs for the purpose of correctly identifying quality attributes (QA). One QA, higher order structure (HOS), is unique to biopharmaceuticals and essential for establishing consistency in biopharmaceutical manufacturing, detecting process-related variations from manufacturing changes and establishing comparability between biologic products. To address this measurement challenge, two-dimensional nuclear magnetic resonance spectroscopy (2D-NMR) methods were introduced that allow for the precise atomic-level comparison of the HOS between two proteins, including mAbs. Here, an inter-laboratory comparison involving 26 industrial, government and academic laboratories worldwide was performed as a benchmark using the NISTmAb, from the National Institute of Standards and Technology (NIST), to facilitate the translation of the 2D-NMR method into routine use for biopharmaceutical product development. Two-dimensional H-1,N-15 and H-1,C-13 NMR spectra were acquired with harmonized experimental protocols on the unlabeled Fab domain and a uniformly enriched-N-15, 20%-C-13-enriched system suitability sample derived from the NISTmAb. Chemometric analyses from over 400 spectral maps acquired on 39 different NMR spectrometers ranging from 500 MHz to 900 MHz demonstrate spectral fingerprints that are fit-for-purpose for the assessment of HOS. The 2D-NMR method is shown to provide the measurement reliability needed to move the technique from an emerging technology to a harmonized, routine measurement that can be generally applied with great confidence to high precision assessments of the HOS of mAb-based biotherapeutics.
|
|
| 2. |
- Hasson, Henna, et al.
(författare)
-
An organizational- level occupational health intervention: Employee perceptions of exposure to changes, and psychosocial outcomes
- 2014
-
Ingår i: Work & Stress. - : Informa UK Limited. - 1464-5335 .- 0267-8373. ; 28:2, s. 179-197
-
Tidskriftsartikel (refereegranskat)abstract
- This study aimed to investigate the association between employees' perceptions of their exposure to an organizational-level occupational health intervention and its psychosocial outcomes. Participants were employees of an insurance firm (N = 1084) in Quebec, Canada. The intervention was designed to reduce adverse psychosocial work factors (high psychological demands, low decision latitude, low social support and low rewards). Departmental managers were responsible for implementing changes to reduce exposure to these factors. Employees' perceptions of exposure to the intervention and its impact on their work were measured in 2007 through questionnaires. Psychological demands, decision latitude, social support and rewards measured in 2005 and 2007 were used to assess outcomes. Employees who perceived that they had been exposed to the intervention changes showed more improvement in outcomes than those who did not perceive changes. The greatest differences in outcomes were found in those participants who perceived that workplace changes had improved their work situation as compared to those who perceived the changes as neutral or negative. The results suggest that measurement of employee-perceived impact of each intervention change on their work situation may be even more important than actual exposure, and should be included in the measurement of exposure to organization-level interventions.
|
|
| 3. |
- Hasson, Henna, et al.
(författare)
-
Implementation of an Organizational-Level Intervention on the Psychosocial Environment of Work: Comparison of Managers' and Employees' Views.
- 2012
-
Ingår i: Journal of Occupational and Environmental Medicine. - 1536-5948. ; 54:1, s. 85-91
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE:: To compare employees' and managers' perceptions of implemented changes in an organizational-level workplace intervention. METHODS:: Nine departments participated in an intervention aimed at reducing adverse psychosocial work environment factors. On the basis of a prior risk evaluation, department managers were responsible for decisions and implementation of the intervention, that is, work changes. These were recorded in logbooks, which were compared to employees' questionnaire ratings of the changes. RESULTS:: For half of the changes, proportion of employees reporting that a specific change was implemented did not correspond with the amount of manager-reported changes. CONCLUSIONS:: Evaluation of employees' and managers' perceptions of an organizational-level intervention is crucial, since these perceptions do not necessarily fully correspond. Employees perceived changes that were not reported by department managers and they also did not perceive exposure to all changes reported by the managers.
|
|
| 4. |
- Jungert, Tomas, et al.
(författare)
-
Autonomous and Controlled Motivation for Parenting: Associations with Parent and Child Outcomes
- 2015
-
Ingår i: Journal of Child and Family Studies. - : Springer Verlag (Germany). - 1062-1024 .- 1573-2843. ; 24:7, s. 1932-1942
-
Tidskriftsartikel (refereegranskat)abstract
- The present investigation examined motivation for parenting and some of its correlates in parents and children. The data came from samples of 151 first-time mothers of infants, 153 mothers of middle school children, and 260 mothers and fathers of high school children. Parents provided self-report data about their motivation in their parenting role as well as reports of role satisfaction, parental competence, child temperament, and parenting styles. Using three samples, factor analyses confirmed the distinction between autonomous and controlled forms of parenting motivation. Autonomous motivation refers to investing in the parenting role because it is interesting and meaningful whereas controlled motivation refers to investment based on external or internal pressures. Results showed that autonomous motivation was associated concurrently with parenting satisfaction and competence as well as with authoritative and autonomy-supportive parenting styles. Child temperament was unrelated to parenting motivation, but mothers reported greater autonomous motivation for girls than boys and for younger children rather than older children. Autonomous parenting motivation was associated with children reporting autonomy supportive parenting and high levels of well-being. A prospective analysis showed that controlled parenting motivation in first time mothers was associated with reductions in parenting satisfaction as infants became toddlers. A similar analysis showed that autonomous parenting motivation was associated with children developing fewer behavior problems whereas controlled motivation was associated with children developing more behavioral problems. The present findings highlight the heuristic value of assessing why parents invest themselves in the parenting role.
|
|
