Health Canada Approval of Miltenyi Biotec PBS/EDTA Solutions
Thursday, August 13, 2020
Posted by: CTTC Head Office
Due to efforts by the CTTC Laboratory Committee, Miltenyi Biotec has clarified the CliniMACS® user manual such that the PBS/EDTA solution is no longer recommended to be washed off at end of cell selection. This will simplify laboratory practice and shorten procedure time, and improve cell yields.
As outlined on page 147 of the CliniMACS® Plus System User Manual (Canadian Edition) issued in June 2020:
“The CliniMACS® PBS/EDTA Buffer does not have to be removed before administration of the separated target cells if the volume does not exceed 100 mL per transplant at appropriate infusion rates. The patient’s renal status and effects on blood electrolytes need to be considered. Especially in children, infusion rates need to be adjusted accordingly.
If the volume of the target cell fraction exceeds 100 mL, it must be reduced by appropriate means, e.g., through centrifugation or buffer exchange, to an infusion solution approved in the country of the user”.
A PDF copy of the CliniMACS® Plus System User Manual (Canadian Edition) can be found here. A hard copy print edition will be available in October 2020.
Thank you to all involved.
Linda Peltier, PhD Nicole Prokopishyn, PhD
Co-Chair, CTTC Laboratory Committee Co-Chair, CTTC Laboratory Committee