Bioprocess Development for Human Mesenchymal Stem Cell Therapy Products

Mesenchymal stem cells (MSCs) are advanced therapy medicinal products used in cell therapy applications. Several MSC products have already advanced to phase III clinical testing and market approval. The manufacturing of MSCs must comply with good manufacturing practice (GMP) from phase I in Europe and phase II in the US, but there are several unique challenges when cells are the therapeutic product. Any GMP-compliant process for the production of MSCs must include the expansion of cells in vitro to achieve a sufficient therapeutic quantity while maintaining high cell quality and potency. The process must also allow the efficient harvest of anchorage-dependent cells and account for the influence of shear stress and other factors, especially during scale-up. Bioreactors are necessary to produce clinical batches of MSCs, and bioprocess development must therefore consider this specialized environment. For the last 10 years, we have investigated bioprocess development as a means to produce high-quality MSCs. More recently, we have also used bioreactors for the cocultivation of stem cells with other adult cells and for the production of MSC-derived extracellular vesicles. This review discusses the state of the art in bioprocess development for the GMP-compliant manufacture of human MSCs as products for stem cell therapy

Coastal horizontal wind speed gradients in the North Sea based on observations and ERA5 reanalysis data

The transition from land to sea affects the wind field in coastal regions. From the perspective of near-coastal offshore wind farms, the coastal transition complicates the task of energy resource assessment by, for example, introducing non-homogeneity into the free wind field. To help elucidate the matter, we quantify the average horizontal wind speed gradients at progressively increasing distances from the German coast using two years of hourly ERA5 reanalysis data, and further describe the dependence of wind speed gradients on the measurement height, atmospheric stability, and season. A vertical wind lidar located on Norderney Island near the German mainland acts as our observational reference for the ERA5 data, where a good agreement ( R 2 = 0 . 9 3 $R^2 =\nobreak 0.93$ ) is found despite the relatively coarse ERA5 data resolution. Interestingly, the comparison of lidar data with the higher-resolution Weather Research and Forecasting (WRF) mesoscale model yields good but relatively weaker agreement ( R 2 = 0 . 8 5 $R^2 =\nobreak 0.85$ ). The ERA5 data reveal that, for flow over the North Sea originating from the German mainland from the south, the wind speed at 10 m (110 m) above sea level increases by 30 % (20 %) some 80 km from the coast on average, and by 5 % at larger heights. An increased stratification increases the horizontal wind speed gradient at 10 m above sea level but decreases it at 110 m. Case studies using satellite and flight measurements are first analyzed to help reveal some of the underlying mechanisms governing horizontal wind speed gradients, including cases of decreasing wind speed with increasing distance from the coast, in which stable flow of warm air over the colder sea leads to an overall deceleration of the flow. The accuracy of offshore resource assessment appears to profit from utilising the horizontal wind speed gradient information contained in ERA5 reanalysis data

Common bacterial responses in six ecosystems exposed to 10 years of elevated atmospheric carbon dioxide

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/91149/1/j.1462-2920.2011.02695.x.pd

Women’s Participation in School Management Shuras in Afghanistan: : Obstacles and Opportunities for Women’s Involvement in Government Schools in Kabul City.

Exponential gains in school enrolment in Afghanistan since 2001 have resulted not only from the efforts of the Ministry of Education, but also from the efforts of communities. Community participation in education in Afghanistan is formalized through school management shuras, parent-teacher councils that have been established and/or strengthened by the MoE through the Education Quality Improvement Program. This research aimed to determine the level of participation of women in school shuras. Empirical research was conducted at 18 schools in Kabul City, in conjunction with the management councils in each school community. Through structured observations and focus group discussions, the research found that women’s participation in school management shuras is more limited than men’s participation and almost negligible in the boys’ schools sampled. This suggests that women’s voices are not much heard concerning the education of their children. The phenomenon may be attributed to prevailing cultural and traditional norms in patriarchal Afghan society, in which men have an upper hand over women in the decisions about schooling, among others. The major recommendation to the Ministry of Education based on this research is that any attempts to increase women’s participation in school management should take into account the existing social framework of Afghan religious and cultural norms. For example, female-only shuras may be elected for girls’ schools, with meetings held in a private home rather than the very public school setting.TEM