Smart Selection Of Leukapheresis Starting Material And Continuous Process Improvement For iPBMC Manufacturing

By T. Cabreros, MS, A. Vijay Kumar, MA, R. Hahn, D. Honda, R. Tressler, PhD, & C. P. Monckton, PhD

Tumor-infiltrating lymphocyte (TIL) therapies rely on irradiated peripheral blood mononuclear cells (iPBMCs) to support expansion and potency. This work presents a refined manufacturing approach that enhances consistency, safety, and cost-efficiency. By identifying impurity thresholds and clotting indicators, donor prescreening was optimized to reduce manufacturing failures. Cryopreservation protocols were adjusted, extending cryosolution exposure times and evaluating alternative materials, to improve cell viability and reduce costs by nearly 60%. A proprietary non-proliferation assay, combined with a performance scoring system, enabled selection of iPBMCs that support robust mononuclear cell expansion, a key proxy for TIL potency. These strategies not only improve product quality but also streamline production and reduce variability across batches.

The result is a more scalable and accessible cell therapy platform that supports broader patient access to advanced immunotherapies. Future development will focus on automation, deeper characterization of cell attributes, and continued cost reduction to further enhance the clinical and commercial viability of TIL-based treatments.