Human-derived raw materials: Controlled, consistent collections enable successful manufacturing of cell-based regenerative medicine products (TECH1P.847)

Abstract

Abstract Human cells are critical raw materials for manufacturing cell therapy products, but introduce significant variability. HemaCare controls apheresis procedures and collection sites under a formal quality system, with GMP-compliant, validated procedures and equipment, and GTP-compliant donor screening and tracking. HemaCare performed 86,799 cellular apheresis collections in the last 7 years for research, clinical trials, and commercial products. HemaCare’s unmobilized apheresis products showed consistently high MNC purity, with 93.8% of products containing ≥75% MNC, and an average of 85.66% MNC±7.1% (mean±1 SD). RBC contamination was low, with hematocrit averaging 1.78%±0.7%. Approximately 85% of HemaCare donors have donated apheresis products 5 or more times. HemaCare’s laboratory is equipped with Miltenyi Biotec technology for isolation of raw material into purified cellular subpopulations. The consistency and viability of the purified end products are measured with flow cytometry. Using BioLife Solutions’ serum-free and protein-free cGMP CryoStor™ cryopreservation media with purified cells, post-thaw recovery rates of cell fractions have been above 95%; dendritic cell and macrophage have demonstrated recovery rates of ≥90%. CryoStor™, in combination with freezing in the BioCision CoolCell™ freezing container, has enabled HemaCare to standardize the cryopreservation process, reducing variability while optimizing post-thaw viable cell recovery of its research products.