Applied Cells is pleased to share that BRL Medicine has used the MARS® Bar platform to support an important manufacturing update for its CAR-T clinical program.
BRL Medicine recently received approval from China’s Center for Drug Evaluation (CDE) for a manufacturing change involving its CD19-targeted, non-viral, site-specific PD1-integrated CAR-T program. The change involved transitioning the CD4/CD8 T-cell selection process from imported magnetic beads to domestically manufactured GMP-grade beads. MARS® Bar served as the automated cell separation platform throughout the validation process, from comparative testing through pilot-scale process development and clinical-scale cell preparation.
The closed, automated platform provided standardized CD4/CD8 T-cell separation and full-process data recording to support the comparability studies required for the manufacturing change. Using MARS® Bar with the GMP-grade CD4/CD8 selection beads, the validated workflow achieved:
- ≥95% target-cell purity
- >90% cell recovery
- >90% post-selection cell viability
Downstream gene-editing and cell-expansion performance was reported to be comparable with the previous process.
Supporting flexible CAR-T manufacturing
The project demonstrates the ability of MARS® Bar to support evolving cell therapy manufacturing processes and different reagent strategies within a closed, automated workflow. With column-free magnetic separation, standardized automated processing and traceable process data, MARS® Bar is designed to help cell therapy developers build consistent workflows from process development through clinical manufacturing. Congratulations to BRL Medicine on this important milestone! We are pleased to see MARS® Bar supporting the continued development of its innovative CAR-T program.
About BRL Medicine
Kat Ginda-Mäkelä
For research use only. Not for use in therapeutic or diagnostic procedures.
