Best Practices in Processing and Storage for Hematopoietic Cell Transplantation 2017
DOI: 10.1007/978-3-319-58949-7_9
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Cord Blood Processing: Different Bags and Automation

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“…3 A major operating change that CB banks had to implement before the FDA license was to switch from a manual processing system to an automated one; the most commonly used systems are AXP (ThermoGenesis) and Sepax (Biosafe); SynGen (ThermoGenesis) is a newer one; these are FDA 510(k) approved. 21 Their advantages include a functionally closed system, to avoid product contamination from the environment, or product cross-contamination during manufacturing, and the ability to handle more products without technical personnel increases. 19 Automated processing allowed for standardisation of the manufacturing process, the final CB product volume and the post-processing haematocrit.…”
Section: Materials Procurement Donor Evaluation and Informed Consentmentioning
confidence: 99%
“…3 A major operating change that CB banks had to implement before the FDA license was to switch from a manual processing system to an automated one; the most commonly used systems are AXP (ThermoGenesis) and Sepax (Biosafe); SynGen (ThermoGenesis) is a newer one; these are FDA 510(k) approved. 21 Their advantages include a functionally closed system, to avoid product contamination from the environment, or product cross-contamination during manufacturing, and the ability to handle more products without technical personnel increases. 19 Automated processing allowed for standardisation of the manufacturing process, the final CB product volume and the post-processing haematocrit.…”
Section: Materials Procurement Donor Evaluation and Informed Consentmentioning
confidence: 99%