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Health Canada Approval of Miltenyi Biotec PBS/EDTA Solutions

Thursday, August 13, 2020   (1 Comments)
Posted by: CTTC Head Office
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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.

 

Best regards,

Linda Peltier, PhD                                                Nicole Prokopishyn, PhD

Co-Chair, CTTC Laboratory Committee              Co-Chair, CTTC Laboratory Committee

Comments...

Michelle Gregory says...
Posted Friday, August 21, 2020
Well done!

 

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