Validation of an automated total and viable cell counting for GMP-compliant production of human bone marrow stromal cells

Bone marrow stromal cells (BMSCs) are classified as Advanced Therapy Medicinal Products (ATMPs) in the subcategory of Cell Therapy Medicinal Products (CTMPs), and the production of these cells for clinical use under good manufacturing practice (GMP) standards is regulated by the European Medicines Agency (EMA). To meet GMP standards for CTMPs, the accuracy and precision of cell-counting methods are essential for monitoring in-process quality and controlling clinical dosing. To achieve this purpose, we validated an automated cell-counting method for evaluating cell concentration and viability, enabling large-scale analysis and reducing analyst-associated variability. Automated cell counting was performed using the LUNA™ automated cell counter, and we validated the parameters against the hemocytometer using the ICH Q2R1 framework. The results showed that automated cell counting yielded acceptable accuracy (90-110%) and RSD (<10%). This demonstrates that LUNA™ automated cell counters may provide an efficient alternative for measuring BMSC cell concentration and viability.