Evaluate The Effects Of Physiologix™ Xeno-Free Serum Replacement Media Supplementation On Critical Quality Attributes

This study compares the impact of Physiologix and fetal bovine serum (FBS) on the growth, expansion, and viability of Mesenchymal stem cells (MSCs). The study primarily focused on the time taken for cultures to attain 80% confluence, Physiologix performance at two concentration levels, and the expression of CD90 as a pluripotency marker. The results showed that MSCs cultured with 5% Physiologix supplementation proliferated faster than those grown in 2% Physiologix or 10% FBS. This suggests that Physiologix could be a more effective supplement for MSC growth and expansion than FBS, which has ethical and safety concerns. The study's findings may have significant implications for cell and gene therapies (CGT), given the increasing regulatory focus on controlling raw materials used in cell culture. The study also found that Physiologix can reduce expansion protocols by at least two days compared to using 10% FBS. Using 5% Physiologix resulted in optimal cell growth, reaching over 80% confluence in four days, compared to six days with 10% FBS. The study confirmed that Physiologix not only improved growth and reduced the time to confluence but also maintained the pluripotency of the MSCs cultures. Consequently, Physiologix could replace bovine fetal calf serum in the culture of therapeutically significant MSCs cell lines.