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SVF assessment and lot release

CR Christopher J. Rogers
RH Robert Harman
MS Mitchell B. Sheinkop
PH Peter Hanson
MA Mary A. Ambach
TD Tal David
RD Rahul Desai
SS Steven Sampson
DA Danielle Aufierro
JB Jay Bowen
GM Gerard Malanga
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After cryopreservation, the QC samples were removed from the storage freezers, thawed, and evaluated for cell count, viability, sterility, endotoxin, and by flow cytometry. In addition, the initial incoming sample was assessed for sterility to assess the collection quality and the shipping impacts.

The dose was determined by the total available SVF cells, with a minimum dose of 2 × 106 nucleated cells and a maximum of 10 × 106 nucleated cells. A cell counter (Nucleocounter by ChemoMetec, Denmark) using a validated propidium iodide cell counting method was used to measure the cell count and viability.

Copyright and License information:  ©2024 Christopher J. Rogers et al., 2024; Published by Mary Ann Liebert, Inc.
This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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