Human-derived raw materials: controlled, consistent collection and cryopreservation enable successful manufacturing of cell-based products

Human cells are critical raw materials for manufacturing cell therapy products, but often introduce significant variability. Rigorous operational controls and quality systems, however, enable optimal collection of high-quality, consistent cellular material. HemaCare, a long-standing supplier of human-derived blood components, 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 seven years (year ending July 31, 2013), including patient and normal-donor peripheral blood mononuclear cells (MNCs), and plateletpheresis products 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). Red blood cell contamination was low, with hematocrit averaging 1.78% ± 0.7%. Approximately 85% of HemaCare donors have donated apheresis products 5 or more times; this repeat-donor pool also contributes to product consistency. HemaCare's laboratory is equipped with Miltenyi Biotec technology for isolation of cellular raw material into purified cellular subpopulations. The consistency and viability of the purified products are measured with flow cytometry. Using BioLife Solutions' serum-free and protein-free fully-defined cGMP CryoStor™ cryopreservation medium with purified cells, post-thaw recovery rates of cell fractions have been above 95%, based on 7AAD staining. Dendritic cells and macrophages have demonstrated post-thaw recovery rates of ≥90%. CryoStor™ cryopreservation medium, 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.