Gaps between Asian regulations for eligibility of human mesenchymal stromal cells as starting materials of cell therapy products and comparability of mesenchymal stromal cell-based products subject to changes in their manufacturing process.

Working group 2 (WG2) of the Asia Partnership Conference of Regenerative Medicine has discussed eligibility of mesenchymal stromal cells (MSCs) as starting cells for the manufacture of cell therapy products, and comparability before and after changes in their manufacturing process. Asian countries and regions have their own regulations on the quality of starting cells, and these regulations are not harmonized. As cell therapy products are being developed across countries and regions, we propose a risk-based approach based on donor location, window period of virus test, and additional virus tests on the master cell bank to fill the gaps in regulation while controlling the risk of viral contamination. Moreover, a standard procedure of comparability assessment after changes in the manufacturing process of MSC-based products does not exist. The WG2 discussed points of comparability assessment specifically for MSC-based products considering the similarities and differences with parallel assessments for protein and polypeptide products, which are within the scope of the International Council for Harmonization Q5E guideline. We also summarize possible characterization procedures for MSC-based products and report our discussion on stability evaluations under accelerated and stress conditions for comparability assessment of cell therapy products.

Changes in the distribution of radiocesium in the wood of Japanese cedar trees from 2011 to 2013.

The changes in the distribution of (137)Cs in the wood of Japanese cedar (Cryptomeria japonica) trunks within three years after the Fukushima Dai-ichi Nuclear Power Plant (FDNP) accident in 2011 were investigated. Thirteen trees were felled to collect samples at 6 forests in 2 regions of the Fukushima prefecture. The radial distribution of (137)Cs in the wood was measured at different heights. Profiles of (137)Cs distribution in the wood changed considerably from 2011 to 2013, and the process of (137)Cs distribution change in the wood was clarified. From 2011 to 2012, the active transportation from sapwood to heartwood and the radial diffusion in heartwood proceeded quickly, and the radial (137)Cs distribution differed according to the vertical positon of trees. From 2012 to 2013, the vertical diffusion of (137)Cs from the treetop to the ground, probably caused by the gradient of (137)Cs concentration in the trunk, was observed. Eventually, the radial (137)Cs distributions were nearly identical at any vertical positions in 2013. Our results suggested that the active transportation from sapwood to heartwood and the vertical and radial diffusion in heartwood proceeded according to the vertical position of the tree and (137)Cs distribution in the wood approached the equilibrium state within three years after the accident.