LAUSR

10 Cord tissue-derived mesenchymal stem cells (CT-MSC) are increasingly being used in clinical studies to address a variety of health issues and diseases due to their tissue-regenerating and immune-modulatory properties. With this promise of therapies comes the need for the manufacturing of a large number of CTMSCs for dosing. At the Marcus Center for Cellular Cures at Duke, we have created a process for the manufacturing of large batches of CT-MSCs. The path from first isolating CT-MSC progenitors from cord tissue to delivery of the appropriate CT-MSC dose at the treatment site comprises many steps that need to be efficiently connected while conforming to current Good Manufacturing Practice standards. The process starts with the isolation of CT-MSC progenitors from donated cord tissue using enzymatic digestion in a tissue dissociator and subsequent culturing in flasks. We have optimized the timing of supplement addition to CT-MSC growth media and cell harvest for obtaining populations of pure CT-MSC. Expansion of those MSCs were initially carried out in cell culture flasks and then broadened to multilayer stacked flask systems in two expansion steps. In order to increase batch size, improve automation, and reduce the number of cell passages, we currently are testing cell expansion in large closed system bioreactors. Parameters tested include loading conditions, media, feed rates, and harvest conditions. Scaling up cell production also has to be matched with up-scaled procedures for cell washing, addition of cryopreservation media, rapid dispensing into suitable cryopreservation containers, and cell cryopreservation. We will briefly review the factors and equipment used at our facility to complete the scaled-up CTMSC process. Supplying the demand of high numbers of quality CT-MSC product requires a manufacturing process that is closedsystem, automated, and efficient in time and cost throughout all steps. We are developing a manufacturing process that will comply with these requirements and that will provide cells for the increasing demand of MSC clinical trials. STEM CELLS TRANSLATIONAL MEDICINE | StemCellsTM.com © AlphaMed Press 2018 PERINATAL TISSUE BANKING AND THERAPIES, INCLUDING MESENCHYMAL STEM CELLS Official journal of the