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Equivalent CD34+ selection outcomes with CliniMACS prodigy and CliniMACS plus, enabling cryopreserved product

Anne-Line Chateau1, Clémence Demerle1, Pierre Lignee1

  • 1Centre de Thérapie Cellulaire, Institut Paoli-Calmettes, Marseille, France; Module Biothérapies du Centre d'Investigation Clinique de Marseille, AP-HM, Aix- Marseille Université, Institut Paoli-Calmettes, CBT-1409 Inserm, Marseille, France.

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Summary

The CliniMACS Prodigy fully automates CD34+ cell selection, matching CliniMACS Plus performance for fresh products and successfully processing thawed apheresis. This improves efficiency and flexibility in cell therapy manufacturing.

Keywords:
CD34 + immunoselectionCliniMACS plusCliniMACS prodigypoor graft functionstem cell boostthawed cellular product

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Area of Science:

  • Cellular immunotherapy
  • Hematopoietic stem cell transplantation
  • Bioprocessing technology

Background:

  • The CliniMACS Plus CS2 device is being discontinued, necessitating a transition to new automated systems.
  • CD34+ immunoselection is crucial for graft engineering in cell therapy and ATMP manufacturing.
  • Evaluating automated platforms is essential for maintaining and improving cell processing workflows.

Purpose of the Study:

  • To validate the CliniMACS Prodigy for CD34+ immunoselection.
  • To assess the performance of the CliniMACS Prodigy using both fresh and thawed apheresis products.
  • To compare the efficiency and outcomes of the CliniMACS Prodigy against the CliniMACS Plus.

Main Methods:

  • CD34+ immunoselection was performed on fresh and thawed apheresis products using CliniMACS Plus and CliniMACS Prodigy.
  • Thawed products were processed after thawing, washing, and resuspension.
  • Flow cytometry was used for quantifying CD34+ and CD45+ cells, and T-cell populations.

Main Results:

  • CliniMACS Prodigy demonstrated comparable CD34+ purity (97%) and viability (99%) to CliniMACS Plus (95% purity, 95% viability) for fresh products.
  • CD34+ recovery was higher with Prodigy (66%) versus Plus (53%), while T-cell depletion was slightly better with Plus.
  • Processing thawed apheresis on Prodigy yielded 98% CD34+ purity, 51% recovery, and acceptable T-cell depletion.
  • Hands-on time was significantly reduced with the automated Prodigy system (2 hours vs. 5 hours).

Conclusions:

  • The CliniMACS Prodigy platform reliably performs CD34+ immunoselection from both fresh and thawed apheresis products.
  • The automated workflow enhances standardization, efficiency, and flexibility in graft engineering and ATMP manufacturing.
  • The ability to process thawed products expands clinical options and utilizes cryopreserved resources.