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Related Experiment Video

Updated: May 28, 2026

A cGMP-applicable Expansion Method for Aggregates of Human Neural Stem and Progenitor Cells Derived From Pluripotent Stem Cells or Fetal Brain Tissue
09:37

A cGMP-applicable Expansion Method for Aggregates of Human Neural Stem and Progenitor Cells Derived From Pluripotent Stem Cells or Fetal Brain Tissue

Published on: June 15, 2014

[Optimization of a haematopoietic stem cell freezing process using a qualification protocol applicable to a

C Thibaudeau1, G Flandrois, E Piteux

  • 1Unité d'ingénierie cellulaire, établissement français du sang, 34, boulevard Jean-Monnet, 44011 Nantes cedex 1, France.

Transfusion Clinique Et Biologique : Journal De La Societe Francaise De Transfusion Sanguine
|October 25, 2011
PubMed
Summary

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A new validation protocol effectively qualifies programmable freezers for hematopoietic stem cell transplantation. This method ensures graft quality and demonstrates improved cellular efficiency in CD34+ stem cells after freezing.

Area of Science:

  • Cellular Biology
  • Cryopreservation Science
  • Biomedical Engineering

Background:

  • The freezing phase is critical for hematopoietic stem cell (HSC) viability.
  • Programmable freezers are recommended for standardizing temperature decrease during HSC cryopreservation.
  • A lack of standardized protocols exists for validating programmable freezers and assessing graft performance during freezing/thawing.

Purpose of the Study:

  • To propose and validate a protocol for qualifying programmable freezers used in HSC cryopreservation.
  • To demonstrate the protocol's ability to prove the performance of freezing and thawing processes for HSC grafts.
  • To optimize programmable freezer capabilities for enhanced HSC graft quality.

Main Methods:

  • A three-phase validation protocol was developed: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

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Cryopreservation and Bioenergetic Evaluation of Human Peripheral Blood Mononuclear Cells
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Cryopreservation and Bioenergetic Evaluation of Human Peripheral Blood Mononuclear Cells

Published on: October 20, 2023

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Last Updated: May 28, 2026

A cGMP-applicable Expansion Method for Aggregates of Human Neural Stem and Progenitor Cells Derived From Pluripotent Stem Cells or Fetal Brain Tissue
09:37

A cGMP-applicable Expansion Method for Aggregates of Human Neural Stem and Progenitor Cells Derived From Pluripotent Stem Cells or Fetal Brain Tissue

Published on: June 15, 2014

Cryopreservation and Bioenergetic Evaluation of Human Peripheral Blood Mononuclear Cells
04:10

Cryopreservation and Bioenergetic Evaluation of Human Peripheral Blood Mononuclear Cells

Published on: October 20, 2023

  • Validation was conducted concurrently using a routine freezer (Nicool Plus) and a new model (Freezal).
  • The protocol assessed the efficacy of the freezing program and its impact on graft quality.

    • Main Results:

    • The proposed protocol successfully demonstrated the efficacy of the freezing program.
    • A significant increase in cellular efficiency of 10% was observed for CD34+ HSCs frozen with the Freezal.
    • The protocol proved the freezer's ability to ensure the quality of grafts for patient reinfusion.

    Conclusions:

    • A novel validation protocol for programmable freezers in HSC cryopreservation has been established.
    • This protocol can optimize programmable freezer performance and validate the freezing/thawing process.
    • The findings support the use of validated programmable freezers to ensure HSC graft quality and improve patient outcomes.