Bioreactor Parameters for Microcarrier-Based Human MSC Expansion under Xeno-Free Conditions in a Vertical-Wheel System

This study describes development and optimization of a xeno-free, fed-batch microcarrier culture process for expansion of human mesenchymal stem/stromal cells in a Vertical-Wheel bioreactor. The authors systematically evaluated inoculation parameters, microcarrier loading conditions, culture strategies, feeding regimens, agitation profiles, and harvest procedures to identify process settings that maximize yield while maintaining cell quality. The fed-batch approach improved media productivity and supported robust cell growth without media exchange during culture. Multiple donor cell lots were evaluated to assess process reproducibility and scalability. Expanded cells retained key phenotypic and functional characteristics following harvest. The publication provides an experimentally validated framework for developing scalable hMSC manufacturing processes suitable for translational research and commercial production environments.