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Related Concept Videos

Overview Of Cell Separation And Isolation01:20

Overview Of Cell Separation And Isolation

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Cell separation was first achieved in 1964 by S. H. Seal, who separated large tumor cells from the smaller blood cells using filtration. Two years later, Pohl and Hawk performed experiments on how cells respond differently to a nonuniform electric field based on the cell type. Such observations were the inception of cell separation methods, which allow isolating a single cell type from a heterogeneous sample.
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Streamlined Methods for Processing and Cryopreservation of Cell Therapy Products Using Automated Systems.

Ye Li1, Hazel Y Stevens1, Srikanth Sivaraman1

  • 1Marcus Center for Therapeutic Cell Characterization and Manufacturing, Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, Georgia, USA.

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|December 29, 2023
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Summary

This study presents streamlined Good Laboratory Practices for processing and cryopreserving cell therapies, ensuring high cell viability for biomanufacturing and clinical use. The protocol is applicable to both adherent mesenchymal stromal cells (MSCs) and suspension peripheral blood mononuclear cells (PBMCs).

Keywords:
Automated systemsBiomanufacturingCell therapiesCryopreservationFinia® Fill and Finish SystemMesenchymal stromal cellsPeripheral blood mononuclear cellsProcess development

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Area of Science:

  • Biotechnology and Biomanufacturing
  • Cell Therapy Development
  • Good Laboratory Practices (GLP)

Background:

  • Cell therapies require robust processing and cryopreservation protocols for successful clinical translation.
  • Current methods may lack standardization, impacting cell viability and product consistency.
  • Good Laboratory Practices are essential for regulatory compliance and reliable biomanufacturing.

Purpose of the Study:

  • To present streamlined procedures for cell therapy processing and cryopreservation applicable to both adherent and suspension cell types.
  • To demonstrate the use of standard biomanufacturing equipment for high-yield cell preparation.
  • To validate cell quality and phenotype post-cryopreservation.

Main Methods:

  • Preparation of adherent mesenchymal stromal cells (MSCs) and suspension peripheral blood mononuclear cells (PBMCs).
  • Cell processing using the Finia® Fill and Finish System and a controlled-rate freezer.
  • Cryopreservation in liquid nitrogen vapor phase followed by cell phenotype and quality metric analysis.

Main Results:

  • Demonstrated applicability to both adherent (MSCs) and suspension (PBMCs) cell types.
  • Maintained high cell viability through controlled temperature and rapid partitioning during cryopreservation.
  • Validated cell quality and phenotype post-processing and cryopreservation.

Conclusions:

  • The presented protocol offers a streamlined, GLP-compliant approach for cell therapy processing and cryopreservation.
  • This method ensures high cell viability and quality, crucial for biomanufacturing and clinical applications.
  • The protocol is scalable for both small- and large-scale cell therapy manufacturing.